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LABELS · 5744cb93-0a8c-19ca-e063-6294a90aecd6

ETOPOSIDE

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
2026-07-23
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. Warnings Etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur.

Indications and usage: exact source text

  1. INDICATIONS AND USAGE Etoposide is indicated in the management of: Small Cell Lung Cancer —Etoposide capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
Full extracted label fields
application numbers
  1. NDA019557
boxed warning exact
  1. Warnings Etoposide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur.
brand names
  1. ETOPOSIDE
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7bc994df-ee84-4ed7-80fa-737f70918953
generic names
  1. ETOPOSIDE
id
5744cb93-0a8c-19ca-e063-6294a90aecd6
indications and usage exact
  1. INDICATIONS AND USAGE Etoposide is indicated in the management of: Small Cell Lung Cancer —Etoposide capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Onesource Specialty Pharma Limited
    matched search terms
    1. cancer
    package ndcs
    1. 83270-451-05
    product ndcs
    1. 83270-451
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 197687
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00300.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
      300
      total
      830
      sha256
      bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
      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=300&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%225744cb93-0a8c-19ca-e063-6294a90aecd6%22
      spl effective date
      2026-07-23
      spl effective time
      20260723
      spl set id
      7bc994df-ee84-4ed7-80fa-737f70918953
      spl version
      2
      substance names
      1. ETOPOSIDE
      uniis
      1. 6PLQ3CP4P3
      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
        NDA019557
        payload
        all indexed label documents
        1. Appl No
          019557
          Application Docs Date
          2012-08-03 00:00:00
          Application Docs ID
          11529
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          28
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          019557
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          28
          Submission Status
          AP
          Submission Status Date
          2002-11-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          019557
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          27
          Submission Status
          AP
          Submission Status Date
          2000-11-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          019557
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          26
          Submission Status
          AP
          Submission Status Date
          2000-02-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          019557
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          23
          Submission Status
          AP
          Submission Status Date
          1999-04-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          019557
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          22
          Submission Status
          AP
          Submission Status Date
          1999-01-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          019557
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          1998-12-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          019557
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          1995-10-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          019557
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          1993-07-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          019557
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          1993-03-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          019557
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          1995-05-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          019557
          Review Priority
          Submission Class Code ID
          3
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          1991-11-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          019557
          Review Priority
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          1991-11-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA019557
        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
        2002-11-05
        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
          019557
          Application Docs Date
          2012-08-03 00:00:00
          Application Docs ID
          11529
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          28
          Submission Type
          SUPPL
        official application record
        Appl No
        019557
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ONESOURCE SPECIALTY
        openfda application present
        true
        products
        1. Active Ingredient
          ETOPOSIDE
          Appl No
          019557
          Drug Name
          VEPESID
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          50MG
          marketing status
          1. Prescription
        2. Active Ingredient
          ETOPOSIDE
          Appl No
          019557
          Drug Name
          VEPESID
          Form
          CAPSULE;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          100MG
          marketing status
          1. Discontinued

      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. NDA019557
      brand names
      1. ETOPOSIDE
      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
      233
      end exclusive
      true
      exact text
      INDICATIONS AND USAGE Etoposide is indicated in the management of: Small Cell Lung Cancer —Etoposide capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
      label id
      5744cb93-0a8c-19ca-e063-6294a90aecd6
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      0d658b80afea46f6892d45c40f3b5e96d23d3bddb37ba9163a97dc221c1d9cd7
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-e1d1d2728ef18d231be0
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. ETOPOSIDE
      id
      ind-span-a1c3e1272531992e4e1f
      label id
      5744cb93-0a8c-19ca-e063-6294a90aecd6
      positive predicate support span
      end
      44
      end exclusive
      true
      exact text
      is indicated
      label id
      5744cb93-0a8c-19ca-e063-6294a90aecd6
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      0d658b80afea46f6892d45c40f3b5e96d23d3bddb37ba9163a97dc221c1d9cd7
      start
      32
      qualifier mentions
      1. context exact
        combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
        kind
        prior_therapy_or_line
        polarity
        not_inferred
        span
        end
        232
        end exclusive
        true
        exact text
        first line treatment in patients with small cell lung cancer
        label id
        5744cb93-0a8c-19ca-e063-6294a90aecd6
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        0d658b80afea46f6892d45c40f3b5e96d23d3bddb37ba9163a97dc221c1d9cd7
        start
        172
      2. context exact
        e management of: Small Cell Lung Cancer —Etoposide capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
        kind
        regimen
        polarity
        not_inferred
        span
        end
        232
        end exclusive
        true
        exact text
        in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer
        label id
        5744cb93-0a8c-19ca-e063-6294a90aecd6
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        0d658b80afea46f6892d45c40f3b5e96d23d3bddb37ba9163a97dc221c1d9cd7
        start
        110
      regulatory links
        schema version
        0.1.0
        source batch sha256
        bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
        source defined aliases
          source span
          end
          233
          end exclusive
          true
          exact text
          INDICATIONS AND USAGE Etoposide is indicated in the management of: Small Cell Lung Cancer —Etoposide capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
          label id
          5744cb93-0a8c-19ca-e063-6294a90aecd6
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          0d658b80afea46f6892d45c40f3b5e96d23d3bddb37ba9163a97dc221c1d9cd7
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%225744cb93-0a8c-19ca-e063-6294a90aecd6%22
          spl effective date
          2026-07-23
          spl set id
          7bc994df-ee84-4ed7-80fa-737f70918953
          spl version
          2
          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

          Preserved source evidence · Not medical advice