Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 35f241ea-eeb8-41b3-9596-be40eb9af06d

Aloprim

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
2022-02-18
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ALOPRIM is indicated for 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 and who cannot tolerate oral therapy. ALOPRIM is a xanthine oxidase inhibitor indicated for 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 and who cannot tolerate oral therapy. ( 1 )
Full extracted label fields
application numbers
  1. NDA020298
boxed warning exact
    brand names
    1. Aloprim
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10cc918f-aa44-415b-932d-2404695ac449
    generic names
    1. ALLOPURINOL
    id
    35f241ea-eeb8-41b3-9596-be40eb9af06d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ALOPRIM is indicated for 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 and who cannot tolerate oral therapy. ALOPRIM is a xanthine oxidase inhibitor indicated for 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 and who cannot tolerate oral therapy. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Mylan Institutional LLC
      matched search terms
      1. cancer
      2. lymphoma
      3. leukemia
      4. tumor
      package ndcs
      1. 67457-187-50
      product ndcs
      1. 67457-187
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 252931
        2. 261265
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00100.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
        100
        total
        830
        sha256
        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
        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=100&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2235f241ea-eeb8-41b3-9596-be40eb9af06d%22
        spl effective date
        2022-02-18
        spl effective time
        20220218
        spl set id
        10cc918f-aa44-415b-932d-2404695ac449
        spl version
        13
        substance names
        1. ALLOPURINOL SODIUM
        uniis
        1. 428673RC2Z
        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
          NDA020298
          payload
          all indexed label documents
          1. Appl No
            020298
            Application Docs Date
            2016-04-04 00:00:00
            Application Docs ID
            12426
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          2. Appl No
            020298
            Application Docs Date
            2020-09-04 00:00:00
            Application Docs ID
            64507
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          3. Appl No
            020298
            Application Docs Date
            2021-01-08 00:00:00
            Application Docs ID
            65874
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          4. Appl No
            020298
            Application Docs Date
            2024-10-07 00:00:00
            Application Docs ID
            79833
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            020298
            Review Priority
            PRIORITY
            Submission Class Code ID
            12
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            1996-05-17 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            020298
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2000-05-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            020298
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2000-01-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            020298
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2013-08-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            020298
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2015-05-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            020298
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2020-08-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            020298
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            2022-02-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            020298
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2020-12-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA020298
          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
          2022-02-17
          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
            020298
            Application Docs Date
            2024-10-07 00:00:00
            Application Docs ID
            79833
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          official application record
          Appl No
          020298
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          MYLAN
          openfda application present
          true
          products
          1. Active Ingredient
            ALLOPURINOL SODIUM
            Appl No
            020298
            Drug Name
            ALOPRIM
            Form
            INJECTABLE;INJECTION
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 500MG BASE/VIAL
            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. NDA020298
        brand names
        1. Aloprim
        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
        482
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ALOPRIM is indicated for 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 and who cannot tolerate oral therapy. ALOPRIM is a xanthine oxidase inhibitor indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which cause
        label id
        35f241ea-eeb8-41b3-9596-be40eb9af06d
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-6da22170ffdeb1610c0b
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. ALLOPURINOL
        id
        ind-span-08f5c59980d62fc64807
        label id
        35f241ea-eeb8-41b3-9596-be40eb9af06d
        positive predicate support span
        end
        44
        end exclusive
        true
        exact text
        is indicated
        label id
        35f241ea-eeb8-41b3-9596-be40eb9af06d
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
        start
        32
        qualifier mentions
        1. context exact
          ATIONS AND USAGE ALOPRIM is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid t
          kind
          age
          polarity
          not_inferred
          span
          end
          72
          end exclusive
          true
          exact text
          adult
          label id
          35f241ea-eeb8-41b3-9596-be40eb9af06d
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
          start
          67
        2. context exact
          USAGE ALOPRIM is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who a
          kind
          age
          polarity
          not_inferred
          span
          end
          95
          end exclusive
          true
          exact text
          pediatric patients
          label id
          35f241ea-eeb8-41b3-9596-be40eb9af06d
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
          start
          77
        regulatory links
          schema version
          0.1.0
          source batch sha256
          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
          source defined aliases
            source span
            end
            282
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE ALOPRIM is indicated for 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 and who cannot tolerate oral therapy.
            label id
            35f241ea-eeb8-41b3-9596-be40eb9af06d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%2235f241ea-eeb8-41b3-9596-be40eb9af06d%22
            spl effective date
            2022-02-18
            spl set id
            10cc918f-aa44-415b-932d-2404695ac449
            spl version
            13
            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 · positive indication candidate
            application numbers
            1. NDA020298
            brand names
            1. Aloprim
            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
            576
            end exclusive
            true
            exact text
            ric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy. ALOPRIM is a xanthine oxidase inhibitor indicated for 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 and who cannot tolerate oral therapy. ( 1 )
            label id
            35f241ea-eeb8-41b3-9596-be40eb9af06d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
            start
            83
            current approval status
            not_reconciled
            duplicate text group
            dup-7ab3d369d9cd3564c9a3
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. ALLOPURINOL
            id
            ind-span-5e4d49b107f367f39c24
            label id
            35f241ea-eeb8-41b3-9596-be40eb9af06d
            positive predicate support span
            end
            332
            end exclusive
            true
            exact text
            is a xanthine oxidase inhibitor indicated
            label id
            35f241ea-eeb8-41b3-9596-be40eb9af06d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
            start
            291
            qualifier mentions
            1. context exact
              xanthine oxidase inhibitor indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid t
              kind
              age
              polarity
              not_inferred
              span
              end
              360
              end exclusive
              true
              exact text
              adult
              label id
              35f241ea-eeb8-41b3-9596-be40eb9af06d
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
              start
              355
            2. context exact
              oxidase inhibitor indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who a
              kind
              age
              polarity
              not_inferred
              span
              end
              383
              end exclusive
              true
              exact text
              pediatric patients
              label id
              35f241ea-eeb8-41b3-9596-be40eb9af06d
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
              start
              365
            regulatory links
              schema version
              0.1.0
              source batch sha256
              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
              source defined aliases
                source span
                end
                570
                end exclusive
                true
                exact text
                ALOPRIM is a xanthine oxidase inhibitor indicated for 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 and who cannot tolerate oral therapy.
                label id
                35f241ea-eeb8-41b3-9596-be40eb9af06d
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
                start
                283
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%2235f241ea-eeb8-41b3-9596-be40eb9af06d%22
                spl effective date
                2022-02-18
                spl set id
                10cc918f-aa44-415b-932d-2404695ac449
                spl version
                13
                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 3 · unclassified context
                application numbers
                1. NDA020298
                brand names
                1. Aloprim
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                576
                end exclusive
                true
                exact text
                ric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy. ( 1 )
                label id
                35f241ea-eeb8-41b3-9596-be40eb9af06d
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
                start
                371
                current approval status
                not_reconciled
                duplicate text group
                dup-7a92d12c82f071d441d0
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. ALLOPURINOL
                id
                ind-span-5165aa630a7d5e54d122
                label id
                35f241ea-eeb8-41b3-9596-be40eb9af06d
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                    source defined aliases
                      source span
                      end
                      576
                      end exclusive
                      true
                      exact text
                      ( 1 )
                      label id
                      35f241ea-eeb8-41b3-9596-be40eb9af06d
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      64d37edce449447e1c832d8355fbee4519d2ced23f37a2c67467403fe0c33c06
                      start
                      571
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%2235f241ea-eeb8-41b3-9596-be40eb9af06d%22
                      spl effective date
                      2022-02-18
                      spl set id
                      10cc918f-aa44-415b-932d-2404695ac449
                      spl version
                      13
                      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

                      Preserved source evidence · Not medical advice