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LABELS · e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d

MERCAPTOPURINE

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
2026-07-20
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 MERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia MERCAPTOPURINE is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
Full extracted label fields
application numbers
  1. NDA205919
boxed warning exact
    brand names
    1. MERCAPTOPURINE
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9c6fc66b-522f-499d-961a-cde6ca0ec2e5
    generic names
    1. MERCAPTOPURINE
    id
    e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE MERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia MERCAPTOPURINE is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Nova Laboratories, Ltd
      matched search terms
      1. leukemia
      package ndcs
      1. 62484-1020-3
      2. 62484-1020-4
      product ndcs
      1. 62484-1020
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 1536484
        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%22e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d%22
        spl effective date
        2026-07-20
        spl effective time
        20260720
        spl set id
        9c6fc66b-522f-499d-961a-cde6ca0ec2e5
        spl version
        6
        substance names
        1. MERCAPTOPURINE
        uniis
        1. E7WED276I5
        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
          NDA205919
          payload
          all indexed label documents
          1. Appl No
            205919
            Application Docs Date
            2014-04-28 00:00:00
            Application Docs ID
            40520
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            205919
            Application Docs Date
            2017-05-09 00:00:00
            Application Docs ID
            48319
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          3. Appl No
            205919
            Application Docs Date
            2018-02-23 00:00:00
            Application Docs ID
            52692
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          4. Appl No
            205919
            Application Docs Date
            2020-04-17 00:00:00
            Application Docs ID
            62589
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          5. Appl No
            205919
            Application Docs Date
            2024-07-15 00:00:00
            Application Docs ID
            79071
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          6. Appl No
            205919
            Application Docs Date
            2024-10-25 00:00:00
            Application Docs ID
            79976
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          7. Appl No
            205919
            Application Docs Date
            2026-07-21 00:00:00
            Application Docs ID
            86619
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2014-04-28 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2014-12-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2017-05-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2018-02-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2020-04-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2024-10-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2024-07-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            205919
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2026-07-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA205919
          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
          2026-07-16
          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
            205919
            Application Docs Date
            2026-07-21 00:00:00
            Application Docs ID
            86619
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          official application record
          Appl No
          205919
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          NOVA LABS LTD
          openfda application present
          true
          products
          1. Active Ingredient
            MERCAPTOPURINE
            Appl No
            205919
            Drug Name
            PURIXAN
            Form
            SUSPENSION;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            20MG/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. NDA205919
        brand names
        1. MERCAPTOPURINE
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        411
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE MERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia MERCAPTOPURINE is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
        label id
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        offset unit
        unicode_code_points
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        source text sha256
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        current approval status
        not_reconciled
        duplicate text group
        dup-e4836aeb05239de0a669
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. MERCAPTOPURINE
        id
        ind-span-6c91224bd480b918a6e7
        label id
        e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d
        positive predicate support span
        end
        84
        end exclusive
        true
        exact text
        is a nucleoside metabolic inhibitor indicated
        label id
        e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
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        qualifier mentions
        1. context exact
          1 INDICATIONS AND USAGE MERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          98
          end exclusive
          true
          exact text
          metabolic inhibitor indicated for the treat
          label id
          e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          6d2759fde5a29027eeb90cf5288a74d4f1f80dd8eb5421508017d431db662416
          start
          55
        regulatory links
          schema version
          0.1.0
          source batch sha256
          24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
          source defined aliases
            source span
            end
            213
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE MERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
            label id
            e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            6d2759fde5a29027eeb90cf5288a74d4f1f80dd8eb5421508017d431db662416
            start
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            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d%22
            spl effective date
            2026-07-20
            spl set id
            9c6fc66b-522f-499d-961a-cde6ca0ec2e5
            spl version
            6
            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
            tumor_directed_candidate
            Passage 2 · unclassified context
            application numbers
            1. NDA205919
            brand names
            1. MERCAPTOPURINE
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
            pending
            content role
            unclassified_context
            context span
            end
            411
            end exclusive
            true
            exact text
            AND USAGE MERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia MERCAPTOPURINE is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
            label id
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            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
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            start
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            current approval status
            not_reconciled
            duplicate text group
            dup-ed6a1f9d576cfdf6b94a
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. MERCAPTOPURINE
            id
            ind-span-6db5f4e9fc7648bcf259
            label id
            e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d
            positive predicate support span
            Source null
            qualifier mentions
              regulatory links
                schema version
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                source batch sha256
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                source defined aliases
                  source span
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                  end exclusive
                  true
                  exact text
                  ( 1.1 )
                  label id
                  e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d
                  offset unit
                  unicode_code_points
                  source array index
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                  source field
                  indications_and_usage_exact
                  source text sha256
                  6d2759fde5a29027eeb90cf5288a74d4f1f80dd8eb5421508017d431db662416
                  start
                  214
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%22e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d%22
                  spl effective date
                  2026-07-20
                  spl set id
                  9c6fc66b-522f-499d-961a-cde6ca0ec2e5
                  spl version
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                  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 · positive indication candidate
                  application numbers
                  1. NDA205919
                  brand names
                  1. MERCAPTOPURINE
                  classification reasons
                  1. explicit_positive_indication_predicate
                  2. tumor_or_malignant_hematology_words_in_positive_statement
                  clinical review status
                  pending
                  content role
                  positive_indication_candidate
                  context span
                  end
                  411
                  end exclusive
                  true
                  exact text
                  E MERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia MERCAPTOPURINE is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
                  label id
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                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
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                  start
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                  current approval status
                  not_reconciled
                  duplicate text group
                  dup-07c6629638c4e105a8bf
                  extraction review status
                  automated_candidate_pending_source_review
                  generic names
                  1. MERCAPTOPURINE
                  id
                  ind-span-efe8b86e287f2d362a8f
                  label id
                  e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d
                  positive predicate support span
                  end
                  282
                  end exclusive
                  true
                  exact text
                  is indicated
                  label id
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                  offset unit
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                  source array index
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                  source field
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                  source text sha256
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                  qualifier mentions
                    regulatory links
                      schema version
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                      source batch sha256
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                      source defined aliases
                        source span
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                        411
                        end exclusive
                        true
                        exact text
                        1.1 Acute Lymphoblastic Leukemia MERCAPTOPURINE is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
                        label id
                        e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        6d2759fde5a29027eeb90cf5288a74d4f1f80dd8eb5421508017d431db662416
                        start
                        222
                        source url
                        https://api.fda.gov/drug/label.json?search=id%3A%22e8f4fd0d-a6b3-4c9c-bf62-78bdb81c703d%22
                        spl effective date
                        2026-07-20
                        spl set id
                        9c6fc66b-522f-499d-961a-cde6ca0ec2e5
                        spl version
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                        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
                        tumor_directed_candidate

                        Preserved source evidence · Not medical advice