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LABELS · 15aec235-80e7-4d95-b48c-bbca69b4b04d

Gastrocrom

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
2024-06-26
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE GASTROCROM is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.
Full extracted label fields
application numbers
  1. NDA020479
boxed warning exact
    brand names
    1. Gastrocrom
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00623958-a8fe-47d1-a0d2-0aa4e2f7966e
    generic names
    1. CROMOLYN SODIUM
    id
    15aec235-80e7-4d95-b48c-bbca69b4b04d
    indications and usage exact
    1. INDICATIONS AND USAGE GASTROCROM is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Viatris Specialty LLC
      matched search terms
      1. mastocytosis
      package ndcs
      1. 0037-0678-08
      2. 0037-0678-96
      product ndcs
      1. 0037-0678
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 831261
        2. 831269
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00000.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
        0
        total
        830
        sha256
        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
        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=0&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2215aec235-80e7-4d95-b48c-bbca69b4b04d%22
        spl effective date
        2024-06-26
        spl effective time
        20240626
        spl set id
        00623958-a8fe-47d1-a0d2-0aa4e2f7966e
        spl version
        6
        substance names
        1. CROMOLYN SODIUM
        uniis
        1. Q2WXR1I0PK
        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
          NDA020479
          payload
          all indexed label documents
            all submission records
            1. Appl No
              020479
              Review Priority
              STANDARD
              Submission Class Code ID
              12
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              1996-02-29 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              020479
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              1999-03-10 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              020479
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              2
              Submission Status
              AP
              Submission Status Date
              2000-02-08 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              020479
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              3
              Submission Status
              AP
              Submission Status Date
              1999-12-16 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              020479
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              5
              Submission Status
              AP
              Submission Status Date
              2003-02-13 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA020479
            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
            2003-02-13
            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
              official application record
              Appl No
              020479
              Appl Public Notes
              Appl Type
              NDA
              Sponsor Name
              VIATRIS SPECIALTY
              openfda application present
              true
              products
              1. Active Ingredient
                CROMOLYN SODIUM
                Appl No
                020479
                Drug Name
                GASTROCROM
                Form
                CONCENTRATE;ORAL
                Product No
                001
                Reference Drug
                1
                Reference Standard
                1
                Strength
                100MG/5ML
                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. NDA020479
            brand names
            1. Gastrocrom
            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
            260
            end exclusive
            true
            exact text
            INDICATIONS AND USAGE GASTROCROM is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.
            label id
            15aec235-80e7-4d95-b48c-bbca69b4b04d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            7a80d193a269bb19e91e435e9803044d4731f00cd59fe718b3c4c5d59e4c4214
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-045eaa97b4a9d4ec7dc1
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. CROMOLYN SODIUM
            id
            ind-span-f0b85f0058adc640622d
            label id
            15aec235-80e7-4d95-b48c-bbca69b4b04d
            positive predicate support span
            end
            45
            end exclusive
            true
            exact text
            is indicated
            label id
            15aec235-80e7-4d95-b48c-bbca69b4b04d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            7a80d193a269bb19e91e435e9803044d4731f00cd59fe718b3c4c5d59e4c4214
            start
            33
            qualifier mentions
              regulatory links
                schema version
                0.1.0
                source batch sha256
                0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
                source defined aliases
                  source span
                  end
                  94
                  end exclusive
                  true
                  exact text
                  INDICATIONS AND USAGE GASTROCROM is indicated in the management of patients with mastocytosis.
                  label id
                  15aec235-80e7-4d95-b48c-bbca69b4b04d
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  7a80d193a269bb19e91e435e9803044d4731f00cd59fe718b3c4c5d59e4c4214
                  start
                  0
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%2215aec235-80e7-4d95-b48c-bbca69b4b04d%22
                  spl effective date
                  2024-06-26
                  spl set id
                  00623958-a8fe-47d1-a0d2-0aa4e2f7966e
                  spl version
                  6
                  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 · unclassified context
                  application numbers
                  1. NDA020479
                  brand names
                  1. Gastrocrom
                  classification reasons
                  1. no_unambiguous_positive_indication_predicate
                  clinical review status
                  pending
                  content role
                  unclassified_context
                  context span
                  end
                  260
                  end exclusive
                  true
                  exact text
                  INDICATIONS AND USAGE GASTROCROM is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.
                  label id
                  15aec235-80e7-4d95-b48c-bbca69b4b04d
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  7a80d193a269bb19e91e435e9803044d4731f00cd59fe718b3c4c5d59e4c4214
                  start
                  0
                  current approval status
                  not_reconciled
                  duplicate text group
                  dup-697248e02ff0dc9f536c
                  extraction review status
                  automated_candidate_pending_source_review
                  generic names
                  1. CROMOLYN SODIUM
                  id
                  ind-span-271980fbb94d45dd5d55
                  label id
                  15aec235-80e7-4d95-b48c-bbca69b4b04d
                  positive predicate support span
                  Source null
                  qualifier mentions
                    regulatory links
                      schema version
                      0.1.0
                      source batch sha256
                      0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
                      source defined aliases
                        source span
                        end
                        260
                        end exclusive
                        true
                        exact text
                        Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.
                        label id
                        15aec235-80e7-4d95-b48c-bbca69b4b04d
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        7a80d193a269bb19e91e435e9803044d4731f00cd59fe718b3c4c5d59e4c4214
                        start
                        95
                        source url
                        https://api.fda.gov/drug/label.json?search=id%3A%2215aec235-80e7-4d95-b48c-bbca69b4b04d%22
                        spl effective date
                        2024-06-26
                        spl set id
                        00623958-a8fe-47d1-a0d2-0aa4e2f7966e
                        spl version
                        6
                        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