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

LABELS · d8871970-cf1c-4cd2-86ed-0565c0dfb5cc

Ga-68-DOTATOC

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
2021-12-08
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Ga 68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Ga 68 DOTATOC Injection is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ( 1 )
Full extracted label fields
application numbers
  1. NDA210828
boxed warning exact
    brand names
    1. Ga-68-DOTATOC
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c4d185c3-d520-462d-ba50-4f4ee485ace3
    generic names
    1. EDOTREOTIDE GALLIUM GA-68
    id
    d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Ga 68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Ga 68 DOTATOC Injection is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. UIHC P E T Imaging Center
      matched search terms
      1. tumors
      package ndcs
      1. 24417-681-30
      product ndcs
      1. 24417-681
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.2 ) 12/2021
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00700.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
        700
        total
        830
        sha256
        24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
        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=700&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22d8871970-cf1c-4cd2-86ed-0565c0dfb5cc%22
        spl effective date
        2021-12-08
        spl effective time
        20211208
        spl set id
        c4d185c3-d520-462d-ba50-4f4ee485ace3
        spl version
        3
        substance names
        1. EDOTREOTIDE GALLIUM GA-68
        uniis
        1. Y68179SY2L
        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
        4. fda_label_posted_after_spl_effective_date_requires_version_review
        Drugs@FDA application source records
        1. application number
          NDA210828
          payload
          all indexed label documents
          1. Appl No
            210828
            Application Docs Date
            2019-09-16 00:00:00
            Application Docs ID
            59782
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            210828
            Application Docs Date
            2021-12-27 00:00:00
            Application Docs ID
            69780
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          3. Appl No
            210828
            Application Docs Date
            2023-07-31 00:00:00
            Application Docs ID
            74930
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            210828
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2019-08-21 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            210828
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2021-12-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            210828
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2023-07-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA210828
          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
          2023-07-27
          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
            210828
            Application Docs Date
            2023-07-31 00:00:00
            Application Docs ID
            74930
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          official application record
          Appl No
          210828
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          UIHC PET IMAGING
          openfda application present
          true
          products
          1. Active Ingredient
            GALLIUM GA-68 EDOTREOTIDE
            Appl No
            210828
            Drug Name
            GALLIUM GA 68 EDOTREOTIDE
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            0.5-4mCi/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. NDA210828
        brand names
        1. Ga-68-DOTATOC
        classification reasons
        1. explicit_positive_indication_predicate
        2. diagnostic_use_words
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        425
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Ga 68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Ga 68 DOTATOC Injection is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in
        label id
        d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-cdd18556b8f736e220ad
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. EDOTREOTIDE GALLIUM GA-68
        id
        ind-span-68328016e4401b678a56
        label id
        d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
        positive predicate support span
        end
        60
        end exclusive
        true
        exact text
        is indicated
        label id
        d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
        start
        48
        qualifier mentions
        1. context exact
          atostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
          kind
          age
          polarity
          not_inferred
          span
          end
          201
          end exclusive
          true
          exact text
          adult
          label id
          d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
          start
          196
        2. context exact
          receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
          kind
          age
          polarity
          not_inferred
          span
          end
          224
          end exclusive
          true
          exact text
          pediatric patients
          label id
          d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
          start
          206
        regulatory links
          schema version
          0.1.0
          source batch sha256
          24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
          source defined aliases
            source span
            end
            225
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE Ga 68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
            label id
            d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22d8871970-cf1c-4cd2-86ed-0565c0dfb5cc%22
            spl effective date
            2021-12-08
            spl set id
            c4d185c3-d520-462d-ba50-4f4ee485ace3
            spl version
            3
            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 · positive indication candidate
            application numbers
            1. NDA210828
            brand names
            1. Ga-68-DOTATOC
            classification reasons
            1. explicit_positive_indication_predicate
            2. diagnostic_use_words
            clinical review status
            pending
            content role
            positive_indication_candidate
            context span
            end
            460
            end exclusive
            true
            exact text
            68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. Ga 68 DOTATOC Injection is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ( 1 )
            label id
            d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
            start
            26
            current approval status
            not_reconciled
            duplicate text group
            dup-95e7a6ff1e4f13749768
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. EDOTREOTIDE GALLIUM GA-68
            id
            ind-span-00e6259a45cfda1db334
            label id
            d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
            positive predicate support span
            end
            293
            end exclusive
            true
            exact text
            is a radioactive diagnostic agent indicated
            label id
            d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
            start
            250
            qualifier mentions
            1. context exact
              atostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
              kind
              age
              polarity
              not_inferred
              span
              end
              430
              end exclusive
              true
              exact text
              adult
              label id
              d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
              start
              425
            2. context exact
              receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
              kind
              age
              polarity
              not_inferred
              span
              end
              453
              end exclusive
              true
              exact text
              pediatric patients
              label id
              d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
              start
              435
            regulatory links
              schema version
              0.1.0
              source batch sha256
              24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
              source defined aliases
                source span
                end
                454
                end exclusive
                true
                exact text
                Ga 68 DOTATOC Injection is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
                label id
                d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
                start
                226
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22d8871970-cf1c-4cd2-86ed-0565c0dfb5cc%22
                spl effective date
                2021-12-08
                spl set id
                c4d185c3-d520-462d-ba50-4f4ee485ace3
                spl version
                3
                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 3 · unclassified context
                application numbers
                1. NDA210828
                brand names
                1. Ga-68-DOTATOC
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                460
                end exclusive
                true
                exact text
                radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. ( 1 )
                label id
                d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
                start
                255
                current approval status
                not_reconciled
                duplicate text group
                dup-405d95ec8ddbf4662ca7
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. EDOTREOTIDE GALLIUM GA-68
                id
                ind-span-4e8eea728f28626af459
                label id
                d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                    source defined aliases
                      source span
                      end
                      460
                      end exclusive
                      true
                      exact text
                      ( 1 )
                      label id
                      d8871970-cf1c-4cd2-86ed-0565c0dfb5cc
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      a67342893c733ffc2b7ddc062d3ac13431f99abee73d00942426d3a14c2cdc65
                      start
                      455
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%22d8871970-cf1c-4cd2-86ed-0565c0dfb5cc%22
                      spl effective date
                      2021-12-08
                      spl set id
                      c4d185c3-d520-462d-ba50-4f4ee485ace3
                      spl version
                      3
                      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