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LABELS · 14a0ad9d-4145-4869-9d8d-747e5d7bfb44

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
2026-05-21
Captured
2026-09-09T23:37:39.774134+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=30ad5ba2-1cef-4933-b104-0597f6a2aaa2
    generic names
    1. ALLOPURINOL
    id
    14a0ad9d-4145-4869-9d8d-747e5d7bfb44
    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
      1. true
      manufacturer names
      1. Rising Pharma Holdings, Inc.
      matched search terms
      1. cancer
      2. lymphoma
      3. leukemia
      4. tumor
      package ndcs
      1. 16571-883-09
      2. 16571-883-01
      3. 16571-883-50
      4. 16571-883-10
      5. 16571-884-09
      6. 16571-884-01
      7. 16571-884-50
      8. 16571-884-10
      9. 16571-885-09
      10. 16571-885-01
      11. 16571-885-50
      12. 16571-885-10
      product ndcs
      1. 16571-883
      2. 16571-884
      3. 16571-885
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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        spl effective date
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        spl effective time
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        spl version
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        substance names
        1. ALLOPURINOL
        uniis
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        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
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            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
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          all submission records
          1. Appl No
            016084
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            52
            Submission Status
            AP
            Submission Status Date
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            Submission Type
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            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
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            Submissions Public Notes
          3. Appl No
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            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission Type
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            Submissions Public Notes
          4. Appl No
            016084
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
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            2023-09-21 00:00:00
            Submission Type
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            Submissions Public Notes
          5. Appl No
            016084
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
            44
            Submission Status
            AP
            Submission Status Date
            2018-12-03 00:00:00
            Submission Type
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            Submissions Public Notes
          6. Appl No
            016084
            Review Priority
            STANDARD
            Submission Class Code ID
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            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
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            Submission No
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            Submission Status
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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
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            Submission No
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            Submission Status
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            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
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          current indication status
          not_reconciled
          has approved submission record
          true
          latest approved submission date
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          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
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            Submission No
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          2. Appl No
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            Application Docs Date
            2023-09-22 00:00:00
            Application Docs ID
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            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            51
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          3. Appl No
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            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
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          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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          SAGE Allopurinol tablet is indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute
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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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