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LABELS · fd96ab4c-d7f4-446f-93d8-1dae246a450a

NUBEQA

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
2025-06-03
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 NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
Full extracted label fields
application numbers
  1. NDA212099
boxed warning exact
    brand names
    1. NUBEQA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a7cb212-56e4-4b9d-a73d-bfee7fe4735e
    generic names
    1. DAROLUTAMIDE
    id
    fd96ab4c-d7f4-446f-93d8-1dae246a450a
    indications and usage exact
    1. 1 INDICATIONS AND USAGE NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Bayer HealthCare Pharmaceuticals Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 50419-395-01
      2. 50419-395-72
      product ndcs
      1. 50419-395
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1 ) 6/2025 Dosage and Administration ( 2.1 ) 6/2025 Warnings and Precautions ( 5.1 , 5.2 ) 6/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2180330
      2. 2180336
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00800.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
      800
      total
      830
      sha256
      8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7
      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=800&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22fd96ab4c-d7f4-446f-93d8-1dae246a450a%22
      spl effective date
      2025-06-03
      spl effective time
      20250603
      spl set id
      1a7cb212-56e4-4b9d-a73d-bfee7fe4735e
      spl version
      23
      substance names
      1. DAROLUTAMIDE
      uniis
      1. X05U0N2RCO
      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
        NDA212099
        payload
        all indexed label documents
        1. Appl No
          212099
          Application Docs Date
          2019-07-31 00:00:00
          Application Docs ID
          59518
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          212099
          Application Docs Date
          2021-01-08 00:00:00
          Application Docs ID
          65873
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          212099
          Application Docs Date
          2022-08-11 00:00:00
          Application Docs ID
          71775
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          212099
          Application Docs Date
          2023-10-16 00:00:00
          Application Docs ID
          75732
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        5. Appl No
          212099
          Application Docs Date
          2025-06-04 00:00:00
          Application Docs ID
          82466
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          212099
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2019-07-30 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          212099
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2021-01-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          212099
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2022-08-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          212099
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2023-10-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          212099
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2025-06-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA212099
        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
        2025-06-03
        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
          212099
          Application Docs Date
          2025-06-04 00:00:00
          Application Docs ID
          82466
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        official application record
        Appl No
        212099
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        BAYER HEALTHCARE
        openfda application present
        true
        products
        1. Active Ingredient
          DAROLUTAMIDE
          Appl No
          212099
          Drug Name
          NUBEQA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          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
      1. NDA212099
      brand names
      1. NUBEQA
      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
      378
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment
      label id
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      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      5a46f9275341b078c945f1a1859119776d9f4505bcc694ff162a8704029aa699
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-96e2735b503a1e558446
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. DAROLUTAMIDE
      id
      ind-span-60746f9784c969208ebf
      label id
      fd96ab4c-d7f4-446f-93d8-1dae246a450a
      positive predicate support span
      end
      74
      end exclusive
      true
      exact text
      is an androgen receptor inhibitor indicated
      label id
      fd96ab4c-d7f4-446f-93d8-1dae246a450a
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
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      start
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      qualifier mentions
      1. context exact
        androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (
        kind
        age
        polarity
        not_inferred
        span
        end
        110
        end exclusive
        true
        exact text
        adult patients
        label id
        fd96ab4c-d7f4-446f-93d8-1dae246a450a
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
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      2. context exact
        tor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC).
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        164
        end exclusive
        true
        exact text
        metastatic castration-resistant prostate ca
        label id
        fd96ab4c-d7f4-446f-93d8-1dae246a450a
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
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      3. context exact
        tor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC).
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        166
        end exclusive
        true
        exact text
        metastatic castration-resistant prostate canc
        label id
        fd96ab4c-d7f4-446f-93d8-1dae246a450a
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        5a46f9275341b078c945f1a1859119776d9f4505bcc694ff162a8704029aa699
        start
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      regulatory links
        schema version
        0.1.0
        source batch sha256
        8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7
        source defined aliases
          source span
          end
          178
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC).
          label id
          fd96ab4c-d7f4-446f-93d8-1dae246a450a
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          5a46f9275341b078c945f1a1859119776d9f4505bcc694ff162a8704029aa699
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22fd96ab4c-d7f4-446f-93d8-1dae246a450a%22
          spl effective date
          2025-06-03
          spl set id
          1a7cb212-56e4-4b9d-a73d-bfee7fe4735e
          spl version
          23
          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. NDA212099
          brand names
          1. NUBEQA
          classification reasons
          1. no_unambiguous_positive_indication_predicate
          clinical review status
          pending
          content role
          unclassified_context
          context span
          end
          441
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant pr
          label id
          fd96ab4c-d7f4-446f-93d8-1dae246a450a
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          5a46f9275341b078c945f1a1859119776d9f4505bcc694ff162a8704029aa699
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-62e1ec7d78e1c6ad86a3
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. DAROLUTAMIDE
          id
          ind-span-2428f236dadd0c0566f5
          label id
          fd96ab4c-d7f4-446f-93d8-1dae246a450a
          positive predicate support span
          Source null
          qualifier mentions
          1. context exact
            ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC).
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            228
            end exclusive
            true
            exact text
            metastatic castration-sensitive prostate ca
            label id
            fd96ab4c-d7f4-446f-93d8-1dae246a450a
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
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          2. context exact
            ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC).
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            230
            end exclusive
            true
            exact text
            metastatic castration-sensitive prostate canc
            label id
            fd96ab4c-d7f4-446f-93d8-1dae246a450a
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
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          regulatory links
            schema version
            0.1.0
            source batch sha256
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            source defined aliases
              source span
              end
              241
              end exclusive
              true
              exact text
              ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC).
              label id
              fd96ab4c-d7f4-446f-93d8-1dae246a450a
              offset unit
              unicode_code_points
              source array index
              0
              source field
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              source text sha256
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              source url
              https://api.fda.gov/drug/label.json?search=id%3A%22fd96ab4c-d7f4-446f-93d8-1dae246a450a%22
              spl effective date
              2025-06-03
              spl set id
              1a7cb212-56e4-4b9d-a73d-bfee7fe4735e
              spl version
              23
              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
              Passage 3 · positive indication candidate
              application numbers
              1. NDA212099
              brand names
              1. NUBEQA
              classification reasons
              1. inherited_predicate_from_same_label_section_requires_review
              2. tumor_or_malignant_hematology_words_in_positive_statement
              clinical review status
              pending
              content role
              positive_indication_candidate
              context span
              end
              534
              end exclusive
              true
              exact text
              gen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic cas
              label id
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              offset unit
              unicode_code_points
              source array index
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              source field
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              source text sha256
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              current approval status
              not_reconciled
              duplicate text group
              dup-0c594aa2ef1d4eb34bdb
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. DAROLUTAMIDE
              id
              ind-span-1a8966180622a46b3b6e
              label id
              fd96ab4c-d7f4-446f-93d8-1dae246a450a
              positive predicate support span
              end
              74
              end exclusive
              true
              exact text
              is an androgen receptor inhibitor indicated
              label id
              fd96ab4c-d7f4-446f-93d8-1dae246a450a
              offset unit
              unicode_code_points
              source array index
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              source field
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              source text sha256
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              qualifier mentions
              1. context exact
                ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
                kind
                biomarker
                polarity
                not_inferred
                span
                end
                291
                end exclusive
                true
                exact text
                metastatic castration-sensitive prostate ca
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                offset unit
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                source text sha256
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              2. context exact
                ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
                kind
                stage_or_setting
                polarity
                not_inferred
                span
                end
                293
                end exclusive
                true
                exact text
                metastatic castration-sensitive prostate canc
                label id
                fd96ab4c-d7f4-446f-93d8-1dae246a450a
                offset unit
                unicode_code_points
                source array index
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                source field
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                source text sha256
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              3. context exact
                1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
                kind
                regimen
                polarity
                not_inferred
                span
                end
                333
                end exclusive
                true
                exact text
                in combination with docetaxel
                label id
                fd96ab4c-d7f4-446f-93d8-1dae246a450a
                offset unit
                unicode_code_points
                source array index
                0
                source field
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                source text sha256
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              regulatory links
                schema version
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                source batch sha256
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                source defined aliases
                  source span
                  end
                  334
                  end exclusive
                  true
                  exact text
                  ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
                  label id
                  fd96ab4c-d7f4-446f-93d8-1dae246a450a
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
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                  source text sha256
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                  start
                  242
                  source url
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                      Preserved source evidence · Not medical advice