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LABELS · e7309808-5ae8-4a55-90e3-3992ace0da62

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
2026-01-30
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS & USAGE Mercaptopurine tablets is a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. (1.1) 1.1 Acute Lymphoblastic Leukemia Mercaptopurine tablets are indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
Full extracted label fields
application numbers
  1. NDA009053
boxed warning exact
    brand names
    1. Mercaptopurine
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e7309808-5ae8-4a55-90e3-3992ace0da62
    generic names
    1. MERCAPTOPURINE
    id
    e7309808-5ae8-4a55-90e3-3992ace0da62
    indications and usage exact
    1. 1 INDICATIONS & USAGE Mercaptopurine tablets is a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. (1.1) 1.1 Acute Lymphoblastic Leukemia Mercaptopurine tablets are indicated for treatment of adult and pediatric 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. Florida Pharmaceutical Products, LLC
      matched search terms
      1. leukemia
      package ndcs
      1. 71921-150-02
      2. 71921-150-25
      product ndcs
      1. 71921-150
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Hepatotoxicity (5.2) 07/2024
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 197931
      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%22e7309808-5ae8-4a55-90e3-3992ace0da62%22
      spl effective date
      2026-01-30
      spl effective time
      20260130
      spl set id
      e7309808-5ae8-4a55-90e3-3992ace0da62
      spl version
      1
      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
      Drugs@FDA application source records
      1. application number
        NDA009053
        payload
        all indexed label documents
        1. Appl No
          009053
          Application Docs Date
          2004-07-21 00:00:00
          Application Docs ID
          10715
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          24
          Submission Type
          SUPPL
        2. Appl No
          009053
          Application Docs Date
          2011-05-31 00:00:00
          Application Docs ID
          10716
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          32
          Submission Type
          SUPPL
        3. Appl No
          009053
          Application Docs Date
          2003-01-10 00:00:00
          Application Docs ID
          32983
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          22
          Submission Type
          SUPPL
        4. Appl No
          009053
          Application Docs Date
          2018-05-24 00:00:00
          Application Docs ID
          54317
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          35
          Submission Type
          SUPPL
        5. Appl No
          009053
          Application Docs Date
          2020-05-01 00:00:00
          Application Docs ID
          62800
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          39
          Submission Type
          SUPPL
        6. Appl No
          009053
          Application Docs Date
          2020-12-31 00:00:00
          Application Docs ID
          65795
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          40
          Submission Type
          SUPPL
        7. Appl No
          009053
          Application Docs Date
          2024-07-12 00:00:00
          Application Docs ID
          79052
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          44
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          009053
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          44
          Submission Status
          AP
          Submission Status Date
          2024-07-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          009053
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          40
          Submission Status
          AP
          Submission Status Date
          2020-12-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          009053
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          39
          Submission Status
          AP
          Submission Status Date
          2020-04-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          009053
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          35
          Submission Status
          AP
          Submission Status Date
          2018-05-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          009053
          Review Priority
          901 REQUIRED
          Submission Class Code ID
          3
          Submission No
          32
          Submission Status
          AP
          Submission Status Date
          2011-05-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          009053
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          24
          Submission Status
          AP
          Submission Status Date
          2004-07-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          009053
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          22
          Submission Status
          AP
          Submission Status Date
          2003-01-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          009053
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          2002-09-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          009053
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          20
          Submission Status
          AP
          Submission Status Date
          2002-03-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          009053
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          19
          Submission Status
          AP
          Submission Status Date
          2001-04-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          009053
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          1996-04-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          009053
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2001-05-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA009053
        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
        2024-07-09
        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
          009053
          Application Docs Date
          2024-07-12 00:00:00
          Application Docs ID
          79052
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          44
          Submission Type
          SUPPL
        official application record
        Appl No
        009053
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        STASON PHARMS
        openfda application present
        true
        products
        1. Active Ingredient
          MERCAPTOPURINE
          Appl No
          009053
          Drug Name
          PURINETHOL
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          50MG
          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. NDA009053
      brand names
      1. Mercaptopurine
      classification reasons
      1. explicit_positive_indication_predicate
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      content role
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      true
      exact text
      1 INDICATIONS & USAGE Mercaptopurine tablets is a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. (1.1) 1.1 Acute Lymphoblastic Leukemia Mercaptopurine tablets are indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy
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      exact text
      is a nucleoside metabolic inhibitor indicated
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      qualifier mentions
      1. context exact
        a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (A
        kind
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        not_inferred
        span
        end
        113
        end exclusive
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        exact text
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      2. context exact
        de metabolic inhibitor indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combin
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        end
        136
        end exclusive
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      3. context exact
        INDICATIONS & USAGE Mercaptopurine tablets is a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients with acute lymphoblastic le
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        span
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        true
        exact text
        metabolic inhibitor indicated for treatment
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          1 INDICATIONS & USAGE Mercaptopurine tablets is a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
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          spl effective date
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          spl set id
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          Source null
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          Passage 2 · unclassified context
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          tablets is a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. (1.1) 1.1 Acute Lymphoblastic Leukemia Mercaptopurine tablets are indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maint
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                    1.1 Acute Lymphoblastic Leukemia Mercaptopurine tablets are indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
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                    source url
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                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    tumor_directed_candidate

                    Preserved source evidence · Not medical advice