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LABELS · f7e04d88-1d9b-47e6-a9ad-deb08af3c098

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
2024-04-01
Captured
2026-09-09T23:38:04.335995+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Allopurinol Tablets are 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 Tablets are not recommended for the treatment of asymptomatic hyperuricemia. Allopurinol Tablets 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 Tablets is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )
Full extracted label fields
application numbers
  1. NDA018832
  2. NDA018877
boxed warning exact
    brand names
    1. Allopurinol
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a80fe56f-8d03-423f-8e2a-7ec8c9e5045b
    generic names
    1. ALLOPURINOL
    id
    f7e04d88-1d9b-47e6-a9ad-deb08af3c098
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Allopurinol Tablets are 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 Tablets are not recommended for the treatment of asymptomatic hyperuricemia. Allopurinol Tablets 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 Tablets is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Actavis Pharma, Inc.
      matched search terms
      1. cancer
      2. lymphoma
      3. leukemia
      4. tumor
      package ndcs
      1. 0591-5543-01
      2. 0591-5543-10
      3. 0591-5544-01
      4. 0591-5544-05
      product ndcs
      1. 0591-5543
      2. 0591-5544
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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        rxcuis
        1. 197319
        2. 197320
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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
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        source url
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        spl effective date
        2024-04-01
        spl effective time
        20240401
        spl set id
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        spl version
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        substance names
        1. ALLOPURINOL
        uniis
        1. 63CZ7GJN5I
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        1. application number
          NDA018832
          payload
          all indexed label documents
          1. Appl No
            018832
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
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            0
            Application Docs Type ID
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            Submission No
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            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
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            Application Docs Type ID
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            Submission No
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            2024-04-03 00:00:00
            Application Docs ID
            78053
            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
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          all submission records
          1. Appl No
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            Submission Status Date
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          2. Appl No
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            STANDARD
            Submission Class Code ID
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            Submission No
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            Submission Status
            AP
            Submission Status Date
            2024-04-03 00:00:00
            Submission Type
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            Submissions Public Notes
          3. Appl No
            018832
            Review Priority
            STANDARD
            Submission Class Code ID
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            Submission No
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            Submission Status
            AP
            Submission Status Date
            2024-04-03 00:00:00
            Submission Type
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            Submissions Public Notes
          4. Appl No
            018832
            Review Priority
            Submission Class Code ID
            4
            Submission No
            55
            Submission Status
            AP
            Submission Status Date
            2014-09-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            018832
            Review Priority
            Submission Class Code ID
            4
            Submission No
            48
            Submission Status
            AP
            Submission Status Date
            2014-09-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            018832
            Review Priority
            Submission Class Code ID
            3
            Submission No
            38
            Submission Status
            AP
            Submission Status Date
            2009-01-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            018832
            Review Priority
            Submission Class Code ID
            4
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            2002-08-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            018832
            Review Priority
            Submission Class Code ID
            4
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            2001-04-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            018832
            Review Priority
            Submission Class Code ID
            4
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2001-02-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            018832
            Review Priority
            Submission Class Code ID
            3
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            2003-08-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            018832
            Review Priority
            Submission Class Code ID
            4
            Submission No
            22
            Submission Status
            AP
            Submission Status Date
            1998-03-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            018832
            Review Priority
            Submission Class Code ID
            4
            Submission No
            21
            Submission Status
            AP
            Submission Status Date
            1998-03-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA018832
          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
          2024-04-03
          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
            018832
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
            78051
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            56
            Submission Type
            SUPPL
          2. Appl No
            018832
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
            78052
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            58
            Submission Type
            SUPPL
          3. Appl No
            018832
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
            78053
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            61
            Submission Type
            SUPPL
          official application record
          Appl No
          018832
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          WATSON LABS
          openfda application present
          true
          products
          1. Active Ingredient
            ALLOPURINOL
            Appl No
            018832
            Drug Name
            ALLOPURINOL
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            0
            Reference Standard
            0
            Strength
            100MG
            marketing status
            1. Prescription
        2. application number
          NDA018877
          payload
          all indexed label documents
          1. Appl No
            018877
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
            78054
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            63
            Submission Type
            SUPPL
          2. Appl No
            018877
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
            78055
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            65
            Submission Type
            SUPPL
          3. Appl No
            018877
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
            78056
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            68
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            018877
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            68
            Submission Status
            AP
            Submission Status Date
            2024-04-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            018877
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            65
            Submission Status
            AP
            Submission Status Date
            2024-04-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            018877
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            63
            Submission Status
            AP
            Submission Status Date
            2024-04-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            018877
            Review Priority
            Submission Class Code ID
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            Submission No
            62
            Submission Status
            AP
            Submission Status Date
            2015-11-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            018877
            Review Priority
            Submission Class Code ID
            3
            Submission No
            45
            Submission Status
            AP
            Submission Status Date
            2009-01-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            018877
            Review Priority
            Submission Class Code ID
            4
            Submission No
            31
            Submission Status
            AP
            Submission Status Date
            2002-08-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            018877
            Review Priority
            Submission Class Code ID
            4
            Submission No
            30
            Submission Status
            AP
            Submission Status Date
            2001-04-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            018877
            Review Priority
            Submission Class Code ID
            4
            Submission No
            29
            Submission Status
            AP
            Submission Status Date
            2001-02-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            018877
            Review Priority
            Submission Class Code ID
            3
            Submission No
            28
            Submission Status
            AP
            Submission Status Date
            2003-08-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            018877
            Review Priority
            Submission Class Code ID
            4
            Submission No
            26
            Submission Status
            AP
            Submission Status Date
            1998-03-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            018877
            Review Priority
            Submission Class Code ID
            4
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            1998-03-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            018877
            Review Priority
            Submission Class Code ID
            4
            Submission No
            21
            Submission Status
            AP
            Submission Status Date
            1993-07-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA018877
          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
          2024-04-03
          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
            018877
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
            78054
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            63
            Submission Type
            SUPPL
          2. Appl No
            018877
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
            78055
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            65
            Submission Type
            SUPPL
          3. Appl No
            018877
            Application Docs Date
            2024-04-03 00:00:00
            Application Docs ID
            78056
            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
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            Submission Type
            SUPPL
          official application record
          Appl No
          018877
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          WATSON LABS
          openfda application present
          true
          products
          1. Active Ingredient
            ALLOPURINOL
            Appl No
            018877
            Drug Name
            ALLOPURINOL
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            300MG
            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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        2. NDA018877
        brand names
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        true
        exact text
        1 INDICATIONS AND USAGE Allopurinol Tablets are 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 Tablets are not recommended for the treatment of asymptomatic hyperuricemia. Allopurinol Tablets 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. context exact
          GE Allopurinol Tablets are indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute
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