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LABELS · 2d6cdaf0-8651-d103-e063-6394a90a9352

Allopurinol

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
2025-02-05
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS & USAGE Allopurinol tablet is indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) Limitations of Use Allopurinol tablet is not recommended for the treatment of asymptomatic hyperuricemia. Allopurinol tablet is a xanthine oxidase inhibitor indicated for the management of: Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) ( 1 ) Adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels ( 1 ) Adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes ( 1 ) Limitations of Use Allopurinol tablet is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )
Full extracted label fields
application numbers
  1. NDA016084
boxed warning exact
    brand names
    1. Allopurinol
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d6ce57f-a9df-319e-e063-6394a90ac93f
    generic names
    1. ALLOPURINOL
    id
    2d6cdaf0-8651-d103-e063-6394a90a9352
    indications and usage exact
    1. 1 INDICATIONS & USAGE Allopurinol tablet is indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) Limitations of Use Allopurinol tablet is not recommended for the treatment of asymptomatic hyperuricemia. Allopurinol tablet is a xanthine oxidase inhibitor indicated for the management of: Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) ( 1 ) Adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels ( 1 ) Adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes ( 1 ) Limitations of Use Allopurinol tablet is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )
    indications and usage tables exact
      is original packager
        manufacturer names
        1. Coupler LLC
        matched search terms
        1. cancer
        2. lymphoma
        3. leukemia
        4. tumor
        package ndcs
        1. 67046-1514-3
        product ndcs
        1. 67046-1514
        product types
        1. HUMAN PRESCRIPTION DRUG
        recent major changes exact
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          1. 197320
          source batch
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          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
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          skip
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          url
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          source url
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          spl effective date
          2025-02-05
          spl effective time
          20250205
          spl set id
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          spl version
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          substance names
          1. ALLOPURINOL
          uniis
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          Drugs@FDA application source records
          1. application number
            NDA016084
            payload
            all indexed label documents
            1. Appl No
              016084
              Application Docs Date
              2018-12-04 00:00:00
              Application Docs ID
              56622
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              44
              Submission Type
              SUPPL
            2. Appl No
              016084
              Application Docs Date
              2022-08-15 00:00:00
              Application Docs ID
              71799
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              49
              Submission Type
              SUPPL
            3. Appl No
              016084
              Application Docs Date
              2023-09-22 00:00:00
              Application Docs ID
              75539
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              48
              Submission Type
              SUPPL
            4. Appl No
              016084
              Application Docs Date
              2023-09-22 00:00:00
              Application Docs ID
              75540
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              51
              Submission Type
              SUPPL
            5. Appl No
              016084
              Application Docs Date
              2023-09-22 00:00:00
              Application Docs ID
              75541
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              52
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              016084
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              52
              Submission Status
              AP
              Submission Status Date
              2023-09-21 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            2. Appl No
              016084
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              51
              Submission Status
              AP
              Submission Status Date
              2023-09-21 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              016084
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              49
              Submission Status
              AP
              Submission Status Date
              2022-08-04 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              016084
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              48
              Submission Status
              AP
              Submission Status Date
              2023-09-21 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              016084
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              44
              Submission Status
              AP
              Submission Status Date
              2018-12-03 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              016084
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              41
              Submission Status
              AP
              Submission Status Date
              2002-07-17 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              016084
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              39
              Submission Status
              AP
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              1991-07-11 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            8. Appl No
              016084
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              38
              Submission Status
              AP
              Submission Status Date
              1985-06-07 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            9. Appl No
              016084
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              37
              Submission Status
              AP
              Submission Status Date
              1985-02-27 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            10. Appl No
              016084
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              36
              Submission Status
              AP
              Submission Status Date
              1983-06-01 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            11. Appl No
              016084
              Review Priority
              Submission Class Code ID
              3
              Submission No
              35
              Submission Status
              AP
              Submission Status Date
              1982-12-08 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            12. Appl No
              016084
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              34
              Submission Status
              AP
              Submission Status Date
              1986-01-27 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA016084
            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
            2023-09-21
            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
              016084
              Application Docs Date
              2023-09-22 00:00:00
              Application Docs ID
              75539
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              48
              Submission Type
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            2. Appl No
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              Application Docs Date
              2023-09-22 00:00:00
              Application Docs ID
              75540
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              51
              Submission Type
              SUPPL
            3. Appl No
              016084
              Application Docs Date
              2023-09-22 00:00:00
              Application Docs ID
              75541
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              52
              Submission Type
              SUPPL
            official application record
            Appl No
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            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            CASPER PHARMA LLC
            openfda application present
            true
            products
            1. Active Ingredient
              ALLOPURINOL
              Appl No
              016084
              Drug Name
              ZYLOPRIM
              Form
              TABLET;ORAL
              Product No
              001
              Reference Drug
              1
              Reference Standard
              0
              Strength
              100MG
              marketing status
              1. Prescription
            2. Active Ingredient
              ALLOPURINOL
              Appl No
              016084
              Drug Name
              ZYLOPRIM
              Form
              TABLET;ORAL
              Product No
              002
              Reference Drug
              1
              Reference Standard
              0
              Strength
              300MG
              marketing status
              1. Prescription
            3. Active Ingredient
              ALLOPURINOL
              Appl No
              016084
              Drug Name
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              Form
              TABLET;ORAL
              Product No
              003
              Reference Drug
              1
              Reference Standard
              0
              Strength
              200MG
              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
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          brand names
          1. Allopurinol
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          1 INDICATIONS & USAGE Allopurinol tablet is indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) Limitations of Use Allopurinol tablet is not recommended for the treatment of asymptomatic hyperuricemia. Allopurinol tablet is a xanthine oxidase inhibitor indicated for the management of: Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric
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              1 INDICATIONS & USAGE Allopurinol tablet is indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) Limitations of Use Allopurinol tablet is not recommended for the treatment of asymptomatic hyperuricemia.
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              n, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) Limitations of Use Allopurinol tablet is not recommended for the treatment of asymptomatic hyperuricemia. Allopurinol tablet is a xanthine oxidase inhibitor indicated for the management of: Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) ( 1 ) Adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels ( 1 ) Adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes ( 1 ) Limitations of Use Allopurinol tablet is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )
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