Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 46dfe43b-1bd0-57a8-e063-6294a90a4c40

Choline C 11

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-12-26
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Choline C 11 Injection is indicated for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer. Choline C 11 Injection is a radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging. In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer ( 1 ).
Full extracted label fields
application numbers
  1. NDA203155
boxed warning exact
    brand names
    1. Choline C 11
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e046642-5038-4094-b1bb-a1915558fb1c
    generic names
    1. CHOLINE C-11
    id
    46dfe43b-1bd0-57a8-e063-6294a90a4c40
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Choline C 11 Injection is indicated for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer. Choline C 11 Injection is a radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging. In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer ( 1 ).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Mayo Clinic
      matched search terms
      1. cancer
      package ndcs
      1. 52670-556-30
      product ndcs
      1. 52670-556
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00200.json
          meta
          disclaimer
          Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
          last updated
          2026-09-09
          results
          limit
          100
          skip
          200
          total
          830
          sha256
          d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
          url
          https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=200&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%2246dfe43b-1bd0-57a8-e063-6294a90a4c40%22
          spl effective date
          2025-12-26
          spl effective time
          20251226
          spl set id
          8e046642-5038-4094-b1bb-a1915558fb1c
          spl version
          10
          substance names
          1. CHOLINE C-11
          uniis
          1. M4AS4XGD4Q
          verification flags
          1. oncology_keyword_candidate_not_clinically_classified
          2. spl_text_not_verified_identical_to_latest_approved_label
          3. individual_indications_not_split_or_reconciled
          Drugs@FDA application source records
          1. application number
            NDA203155
            payload
            all indexed label documents
            1. Appl No
              203155
              Application Docs Date
              2012-09-14 00:00:00
              Application Docs ID
              19435
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            2. Appl No
              203155
              Application Docs Date
              2024-09-10 00:00:00
              Application Docs ID
              79569
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              9
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              203155
              Review Priority
              PRIORITY
              Submission Class Code ID
              7
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2012-09-12 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              203155
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2013-07-26 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              203155
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              2
              Submission Status
              AP
              Submission Status Date
              2013-10-30 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              203155
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              4
              Submission Status
              AP
              Submission Status Date
              2015-03-30 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              203155
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              5
              Submission Status
              AP
              Submission Status Date
              2015-10-28 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              203155
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              9
              Submission Status
              AP
              Submission Status Date
              2024-09-09 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              203155
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              33
              Submission Status
              AP
              Submission Status Date
              2014-11-16 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA203155
            approval interpretation
            Application linkage and approved submission are not indication-level current approval verification
            current indication status
            not_reconciled
            has approved submission record
            true
            latest approved submission date
            2024-09-09
            latest label selection rule
            max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
            latest posted label documents
            1. Appl No
              203155
              Application Docs Date
              2024-09-10 00:00:00
              Application Docs ID
              79569
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              9
              Submission Type
              SUPPL
            official application record
            Appl No
            203155
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            MCPRF
            openfda application present
            true
            products
            1. Active Ingredient
              CHOLINE C-11
              Appl No
              203155
              Drug Name
              CHOLINE C-11
              Form
              INJECTABLE;INTRAVENOUS
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              4-33.1mCi/ML
              marketing status
              1. Prescription

          Source passages and status connections

          Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

          Passage 1 · positive indication candidate
          application numbers
          1. NDA203155
          brand names
          1. Choline C 11
          classification reasons
          1. explicit_positive_indication_predicate
          2. diagnostic_use_words
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          465
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE Choline C 11 Injection is indicated for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevate
          label id
          46dfe43b-1bd0-57a8-e063-6294a90a4c40
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-500587c860cec1b0984b
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. CHOLINE C-11
          id
          ind-span-57a1a0698d762d369ba7
          label id
          46dfe43b-1bd0-57a8-e063-6294a90a4c40
          positive predicate support span
          end
          59
          end exclusive
          true
          exact text
          is indicated
          label id
          46dfe43b-1bd0-57a8-e063-6294a90a4c40
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
          start
          47
          qualifier mentions
            regulatory links
              schema version
              0.1.0
              source batch sha256
              d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
              source defined aliases
                source span
                end
                265
                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE Choline C 11 Injection is indicated for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI).
                label id
                46dfe43b-1bd0-57a8-e063-6294a90a4c40
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                start
                0
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%2246dfe43b-1bd0-57a8-e063-6294a90a4c40%22
                spl effective date
                2025-12-26
                spl set id
                8e046642-5038-4094-b1bb-a1915558fb1c
                spl version
                10
                structured fields status
                not_extracted_no_values_inferred_from_mentions
                structured indication
                age
                Source null
                approval pathway
                Source null
                biomarker and test
                Source null
                disease stage
                Source null
                limitations
                Source null
                line
                Source null
                prior therapy
                Source null
                regimen
                Source null
                tumor histology
                Source null
                use intent
                diagnostic_candidate
                Passage 2 · unclassified context
                application numbers
                1. NDA203155
                brand names
                1. Choline C 11
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                613
                end exclusive
                true
                exact text
                sitron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limi
                label id
                46dfe43b-1bd0-57a8-e063-6294a90a4c40
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                start
                66
                current approval status
                not_reconciled
                duplicate text group
                dup-fa6c1a7e62a3f7ff3898
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. CHOLINE C-11
                id
                ind-span-fab2634450726ea2025b
                label id
                46dfe43b-1bd0-57a8-e063-6294a90a4c40
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                    source defined aliases
                      source span
                      end
                      413
                      end exclusive
                      true
                      exact text
                      In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation.
                      label id
                      46dfe43b-1bd0-57a8-e063-6294a90a4c40
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                      start
                      266
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%2246dfe43b-1bd0-57a8-e063-6294a90a4c40%22
                      spl effective date
                      2025-12-26
                      spl set id
                      8e046642-5038-4094-b1bb-a1915558fb1c
                      spl version
                      10
                      structured fields status
                      not_extracted_no_values_inferred_from_mentions
                      structured indication
                      age
                      Source null
                      approval pathway
                      Source null
                      biomarker and test
                      Source null
                      disease stage
                      Source null
                      limitations
                      Source null
                      line
                      Source null
                      prior therapy
                      Source null
                      regimen
                      Source null
                      tumor histology
                      Source null
                      use intent
                      unclear
                      Passage 3 · unclassified context
                      application numbers
                      1. NDA203155
                      brand names
                      1. Choline C 11
                      classification reasons
                      1. no_unambiguous_positive_indication_predicate
                      clinical review status
                      pending
                      content role
                      unclassified_context
                      context span
                      end
                      738
                      end exclusive
                      true
                      exact text
                      omography (CT) or magnetic resonance imaging (MRI). In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer. Choli
                      label id
                      46dfe43b-1bd0-57a8-e063-6294a90a4c40
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                      start
                      214
                      current approval status
                      not_reconciled
                      duplicate text group
                      dup-7773d381642741d6a4ff
                      extraction review status
                      automated_candidate_pending_source_review
                      generic names
                      1. CHOLINE C-11
                      id
                      ind-span-58270bfc952c6aa3c8fb
                      label id
                      46dfe43b-1bd0-57a8-e063-6294a90a4c40
                      positive predicate support span
                      Source null
                      qualifier mentions
                        regulatory links
                          schema version
                          0.1.0
                          source batch sha256
                          d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                          source defined aliases
                            source span
                            end
                            538
                            end exclusive
                            true
                            exact text
                            Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.
                            label id
                            46dfe43b-1bd0-57a8-e063-6294a90a4c40
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                            start
                            414
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%2246dfe43b-1bd0-57a8-e063-6294a90a4c40%22
                            spl effective date
                            2025-12-26
                            spl set id
                            8e046642-5038-4094-b1bb-a1915558fb1c
                            spl version
                            10
                            structured fields status
                            not_extracted_no_values_inferred_from_mentions
                            structured indication
                            age
                            Source null
                            approval pathway
                            Source null
                            biomarker and test
                            Source null
                            disease stage
                            Source null
                            limitations
                            Source null
                            line
                            Source null
                            prior therapy
                            Source null
                            regimen
                            Source null
                            tumor histology
                            Source null
                            use intent
                            unclear
                            Passage 4 · unclassified context
                            application numbers
                            1. NDA203155
                            brand names
                            1. Choline C 11
                            classification reasons
                            1. no_unambiguous_positive_indication_predicate
                            clinical review status
                            pending
                            content role
                            unclassified_context
                            context span
                            end
                            808
                            end exclusive
                            true
                            exact text
                            ites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer. Choline C 11 Injection is a radioactive diagnostic agent for positron emiss
                            label id
                            46dfe43b-1bd0-57a8-e063-6294a90a4c40
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                            start
                            339
                            current approval status
                            not_reconciled
                            duplicate text group
                            dup-61e8317aa1e1f42acd07
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. CHOLINE C-11
                            id
                            ind-span-a08ba232fac7b4575fa9
                            label id
                            46dfe43b-1bd0-57a8-e063-6294a90a4c40
                            positive predicate support span
                            Source null
                            qualifier mentions
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                source defined aliases
                                  source span
                                  end
                                  608
                                  end exclusive
                                  true
                                  exact text
                                  In clinical studies, images were produced with PET/CT coregistration.
                                  label id
                                  46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                  start
                                  539
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%2246dfe43b-1bd0-57a8-e063-6294a90a4c40%22
                                  spl effective date
                                  2025-12-26
                                  spl set id
                                  8e046642-5038-4094-b1bb-a1915558fb1c
                                  spl version
                                  10
                                  structured fields status
                                  not_extracted_no_values_inferred_from_mentions
                                  structured indication
                                  age
                                  Source null
                                  approval pathway
                                  Source null
                                  biomarker and test
                                  Source null
                                  disease stage
                                  Source null
                                  limitations
                                  Source null
                                  line
                                  Source null
                                  prior therapy
                                  Source null
                                  regimen
                                  Source null
                                  tumor histology
                                  Source null
                                  use intent
                                  unclear
                                  Passage 5 · unclassified context
                                  application numbers
                                  1. NDA203155
                                  brand names
                                  1. Choline C 11
                                  classification reasons
                                  1. no_unambiguous_positive_indication_predicate
                                  clinical review status
                                  pending
                                  content role
                                  unclassified_context
                                  context span
                                  end
                                  932
                                  end exclusive
                                  true
                                  exact text
                                  ion. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer. Choline C 11 Injection is a radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, co
                                  label id
                                  46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                  start
                                  409
                                  current approval status
                                  not_reconciled
                                  duplicate text group
                                  dup-f5a5bc1468270264e77e
                                  extraction review status
                                  automated_candidate_pending_source_review
                                  generic names
                                  1. CHOLINE C-11
                                  id
                                  ind-span-e90a9242277af87092fb
                                  label id
                                  46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                  positive predicate support span
                                  Source null
                                  qualifier mentions
                                  1. context exact
                                    imaging is not a replacement for histologic verification of recurrent prostate cancer.
                                    kind
                                    stage_or_setting
                                    polarity
                                    not_inferred
                                    span
                                    end
                                    731
                                    end exclusive
                                    true
                                    exact text
                                    recurrent prostate cancer
                                    label id
                                    46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                    start
                                    706
                                  regulatory links
                                    schema version
                                    0.1.0
                                    source batch sha256
                                    d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                    source defined aliases
                                      source span
                                      end
                                      732
                                      end exclusive
                                      true
                                      exact text
                                      Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer.
                                      label id
                                      46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                      start
                                      609
                                      source url
                                      https://api.fda.gov/drug/label.json?search=id%3A%2246dfe43b-1bd0-57a8-e063-6294a90a4c40%22
                                      spl effective date
                                      2025-12-26
                                      spl set id
                                      8e046642-5038-4094-b1bb-a1915558fb1c
                                      spl version
                                      10
                                      structured fields status
                                      not_extracted_no_values_inferred_from_mentions
                                      structured indication
                                      age
                                      Source null
                                      approval pathway
                                      Source null
                                      biomarker and test
                                      Source null
                                      disease stage
                                      Source null
                                      limitations
                                      Source null
                                      line
                                      Source null
                                      prior therapy
                                      Source null
                                      regimen
                                      Source null
                                      tumor histology
                                      Source null
                                      use intent
                                      unclear
                                      Passage 6 · unclassified context
                                      application numbers
                                      1. NDA203155
                                      brand names
                                      1. Choline C 11
                                      classification reasons
                                      1. no_unambiguous_positive_indication_predicate
                                      clinical review status
                                      pending
                                      content role
                                      unclassified_context
                                      context span
                                      end
                                      1189
                                      end exclusive
                                      true
                                      exact text
                                      rapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer. Choline C 11 Injection is a radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging. In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevate
                                      label id
                                      46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                      start
                                      533
                                      current approval status
                                      not_reconciled
                                      duplicate text group
                                      dup-6ac2da19ca2eb4444f92
                                      extraction review status
                                      automated_candidate_pending_source_review
                                      generic names
                                      1. CHOLINE C-11
                                      id
                                      ind-span-9864c315c1588fbd11a2
                                      label id
                                      46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                      positive predicate support span
                                      Source null
                                      qualifier mentions
                                        regulatory links
                                          schema version
                                          0.1.0
                                          source batch sha256
                                          d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                          source defined aliases
                                            source span
                                            end
                                            989
                                            end exclusive
                                            true
                                            exact text
                                            Choline C 11 Injection is a radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging.
                                            label id
                                            46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                            start
                                            733
                                            source url
                                            https://api.fda.gov/drug/label.json?search=id%3A%2246dfe43b-1bd0-57a8-e063-6294a90a4c40%22
                                            spl effective date
                                            2025-12-26
                                            spl set id
                                            8e046642-5038-4094-b1bb-a1915558fb1c
                                            spl version
                                            10
                                            structured fields status
                                            not_extracted_no_values_inferred_from_mentions
                                            structured indication
                                            age
                                            Source null
                                            approval pathway
                                            Source null
                                            biomarker and test
                                            Source null
                                            disease stage
                                            Source null
                                            limitations
                                            Source null
                                            line
                                            Source null
                                            prior therapy
                                            Source null
                                            regimen
                                            Source null
                                            tumor histology
                                            Source null
                                            use intent
                                            unclear
                                            Passage 7 · unclassified context
                                            application numbers
                                            1. NDA203155
                                            brand names
                                            1. Choline C 11
                                            classification reasons
                                            1. no_unambiguous_positive_indication_predicate
                                            clinical review status
                                            pending
                                            content role
                                            unclassified_context
                                            context span
                                            end
                                            1337
                                            end exclusive
                                            true
                                            exact text
                                            for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging. In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limi
                                            label id
                                            46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                            start
                                            790
                                            current approval status
                                            not_reconciled
                                            duplicate text group
                                            dup-fa6c1a7e62a3f7ff3898
                                            extraction review status
                                            automated_candidate_pending_source_review
                                            generic names
                                            1. CHOLINE C-11
                                            id
                                            ind-span-50dad9f465086b076ac9
                                            label id
                                            46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                            positive predicate support span
                                            Source null
                                            qualifier mentions
                                              regulatory links
                                                schema version
                                                0.1.0
                                                source batch sha256
                                                d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                                source defined aliases
                                                  source span
                                                  end
                                                  1137
                                                  end exclusive
                                                  true
                                                  exact text
                                                  In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation.
                                                  label id
                                                  46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                                  start
                                                  990
                                                  source url
                                                  https://api.fda.gov/drug/label.json?search=id%3A%2246dfe43b-1bd0-57a8-e063-6294a90a4c40%22
                                                  spl effective date
                                                  2025-12-26
                                                  spl set id
                                                  8e046642-5038-4094-b1bb-a1915558fb1c
                                                  spl version
                                                  10
                                                  structured fields status
                                                  not_extracted_no_values_inferred_from_mentions
                                                  structured indication
                                                  age
                                                  Source null
                                                  approval pathway
                                                  Source null
                                                  biomarker and test
                                                  Source null
                                                  disease stage
                                                  Source null
                                                  limitations
                                                  Source null
                                                  line
                                                  Source null
                                                  prior therapy
                                                  Source null
                                                  regimen
                                                  Source null
                                                  tumor histology
                                                  Source null
                                                  use intent
                                                  unclear
                                                  Passage 8 · unclassified context
                                                  application numbers
                                                  1. NDA203155
                                                  brand names
                                                  1. Choline C 11
                                                  classification reasons
                                                  1. no_unambiguous_positive_indication_predicate
                                                  clinical review status
                                                  pending
                                                  content role
                                                  unclassified_context
                                                  context span
                                                  end
                                                  1462
                                                  end exclusive
                                                  true
                                                  exact text
                                                  ized tomography (CT) or magnetic resonance imaging. In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer ( 1 ).
                                                  label id
                                                  46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                                  start
                                                  938
                                                  current approval status
                                                  not_reconciled
                                                  duplicate text group
                                                  dup-7773d381642741d6a4ff
                                                  extraction review status
                                                  automated_candidate_pending_source_review
                                                  generic names
                                                  1. CHOLINE C-11
                                                  id
                                                  ind-span-109629c695800088810d
                                                  label id
                                                  46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                                  positive predicate support span
                                                  Source null
                                                  qualifier mentions
                                                    regulatory links
                                                      schema version
                                                      0.1.0
                                                      source batch sha256
                                                      d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                                      source defined aliases
                                                        source span
                                                        end
                                                        1262
                                                        end exclusive
                                                        true
                                                        exact text
                                                        Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.
                                                        label id
                                                        46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                                        start
                                                        1138
                                                        source url
                                                        https://api.fda.gov/drug/label.json?search=id%3A%2246dfe43b-1bd0-57a8-e063-6294a90a4c40%22
                                                        spl effective date
                                                        2025-12-26
                                                        spl set id
                                                        8e046642-5038-4094-b1bb-a1915558fb1c
                                                        spl version
                                                        10
                                                        structured fields status
                                                        not_extracted_no_values_inferred_from_mentions
                                                        structured indication
                                                        age
                                                        Source null
                                                        approval pathway
                                                        Source null
                                                        biomarker and test
                                                        Source null
                                                        disease stage
                                                        Source null
                                                        limitations
                                                        Source null
                                                        line
                                                        Source null
                                                        prior therapy
                                                        Source null
                                                        regimen
                                                        Source null
                                                        tumor histology
                                                        Source null
                                                        use intent
                                                        unclear
                                                        Passage 9 · unclassified context
                                                        application numbers
                                                        1. NDA203155
                                                        brand names
                                                        1. Choline C 11
                                                        classification reasons
                                                        1. no_unambiguous_positive_indication_predicate
                                                        clinical review status
                                                        pending
                                                        content role
                                                        unclassified_context
                                                        context span
                                                        end
                                                        1462
                                                        end exclusive
                                                        true
                                                        exact text
                                                        ites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer ( 1 ).
                                                        label id
                                                        46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                                        start
                                                        1063
                                                        current approval status
                                                        not_reconciled
                                                        duplicate text group
                                                        dup-61e8317aa1e1f42acd07
                                                        extraction review status
                                                        automated_candidate_pending_source_review
                                                        generic names
                                                        1. CHOLINE C-11
                                                        id
                                                        ind-span-32bed408b87c8bb4f795
                                                        label id
                                                        46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                                        positive predicate support span
                                                        Source null
                                                        qualifier mentions
                                                          regulatory links
                                                            schema version
                                                            0.1.0
                                                            source batch sha256
                                                            d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                                            source defined aliases
                                                              source span
                                                              end
                                                              1332
                                                              end exclusive
                                                              true
                                                              exact text
                                                              In clinical studies, images were produced with PET/CT coregistration.
                                                              label id
                                                              46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                                              offset unit
                                                              unicode_code_points
                                                              source array index
                                                              0
                                                              source field
                                                              indications_and_usage_exact
                                                              source text sha256
                                                              138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                                              start
                                                              1263
                                                              source url
                                                              https://api.fda.gov/drug/label.json?search=id%3A%2246dfe43b-1bd0-57a8-e063-6294a90a4c40%22
                                                              spl effective date
                                                              2025-12-26
                                                              spl set id
                                                              8e046642-5038-4094-b1bb-a1915558fb1c
                                                              spl version
                                                              10
                                                              structured fields status
                                                              not_extracted_no_values_inferred_from_mentions
                                                              structured indication
                                                              age
                                                              Source null
                                                              approval pathway
                                                              Source null
                                                              biomarker and test
                                                              Source null
                                                              disease stage
                                                              Source null
                                                              limitations
                                                              Source null
                                                              line
                                                              Source null
                                                              prior therapy
                                                              Source null
                                                              regimen
                                                              Source null
                                                              tumor histology
                                                              Source null
                                                              use intent
                                                              unclear
                                                              Passage 10 · unclassified context
                                                              application numbers
                                                              1. NDA203155
                                                              brand names
                                                              1. Choline C 11
                                                              classification reasons
                                                              1. no_unambiguous_positive_indication_predicate
                                                              clinical review status
                                                              pending
                                                              content role
                                                              unclassified_context
                                                              context span
                                                              end
                                                              1462
                                                              end exclusive
                                                              true
                                                              exact text
                                                              ion. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer ( 1 ).
                                                              label id
                                                              46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                                              offset unit
                                                              unicode_code_points
                                                              source array index
                                                              0
                                                              source field
                                                              indications_and_usage_exact
                                                              source text sha256
                                                              138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                                              start
                                                              1133
                                                              current approval status
                                                              not_reconciled
                                                              duplicate text group
                                                              dup-be106dc418a35cfc263d
                                                              extraction review status
                                                              automated_candidate_pending_source_review
                                                              generic names
                                                              1. CHOLINE C-11
                                                              id
                                                              ind-span-245d7a482facc28d9008
                                                              label id
                                                              46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                                              positive predicate support span
                                                              Source null
                                                              qualifier mentions
                                                              1. context exact
                                                                imaging is not a replacement for histologic verification of recurrent prostate cancer ( 1 ).
                                                                kind
                                                                stage_or_setting
                                                                polarity
                                                                not_inferred
                                                                span
                                                                end
                                                                1461
                                                                end exclusive
                                                                true
                                                                exact text
                                                                recurrent prostate cancer ( 1 )
                                                                label id
                                                                46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                                                offset unit
                                                                unicode_code_points
                                                                source array index
                                                                0
                                                                source field
                                                                indications_and_usage_exact
                                                                source text sha256
                                                                138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                                                start
                                                                1430
                                                              regulatory links
                                                                schema version
                                                                0.1.0
                                                                source batch sha256
                                                                d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                                                source defined aliases
                                                                  source span
                                                                  end
                                                                  1462
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer ( 1 ).
                                                                  label id
                                                                  46dfe43b-1bd0-57a8-e063-6294a90a4c40
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  138eb802e95d14463c0c059407bdc8e69db1466c23a48624c40d7bec984070ae
                                                                  start
                                                                  1333
                                                                  source url
                                                                  https://api.fda.gov/drug/label.json?search=id%3A%2246dfe43b-1bd0-57a8-e063-6294a90a4c40%22
                                                                  spl effective date
                                                                  2025-12-26
                                                                  spl set id
                                                                  8e046642-5038-4094-b1bb-a1915558fb1c
                                                                  spl version
                                                                  10
                                                                  structured fields status
                                                                  not_extracted_no_values_inferred_from_mentions
                                                                  structured indication
                                                                  age
                                                                  Source null
                                                                  approval pathway
                                                                  Source null
                                                                  biomarker and test
                                                                  Source null
                                                                  disease stage
                                                                  Source null
                                                                  limitations
                                                                  Source null
                                                                  line
                                                                  Source null
                                                                  prior therapy
                                                                  Source null
                                                                  regimen
                                                                  Source null
                                                                  tumor histology
                                                                  Source null
                                                                  use intent
                                                                  unclear

                                                                  Preserved source evidence · Not medical advice