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

LABELS · aacccc63-aa7d-435e-bec5-0aab0e04153f

PROGESTERONE

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
2022-10-05
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
Full extracted label fields
application numbers
  1. NDA017362
boxed warning exact
    brand names
    1. PROGESTERONE
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a09a3b76-36f1-4d20-930e-7e3da97e7ebd
    generic names
    1. PROGESTERONE
    id
    aacccc63-aa7d-435e-bec5-0aab0e04153f
    indications and usage exact
    1. INDICATIONS AND USAGE This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Actavis Pharma, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 0591-3128-79
      product ndcs
      1. 0591-3128
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAMUSCULAR
        rxcuis
        1. 312644
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00500.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
        500
        total
        830
        sha256
        424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
        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=500&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22aacccc63-aa7d-435e-bec5-0aab0e04153f%22
        spl effective date
        2022-10-05
        spl effective time
        20221005
        spl set id
        a09a3b76-36f1-4d20-930e-7e3da97e7ebd
        spl version
        23
        substance names
        1. PROGESTERONE
        uniis
        1. 4G7DS2Q64Y
        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
          NDA017362
          payload
          all indexed label documents
          1. Appl No
            017362
            Application Docs Date
            2007-01-16 00:00:00
            Application Docs ID
            33242
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            104
            Submission Type
            SUPPL
          2. Appl No
            017362
            Application Docs Date
            2018-08-24 00:00:00
            Application Docs ID
            55298
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            111
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            48
            Submission Status
            AP
            Submission Status Date
            1978-12-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            51
            Submission Status
            AP
            Submission Status Date
            1979-08-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            52
            Submission Status
            AP
            Submission Status Date
            1979-08-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            53
            Submission Status
            AP
            Submission Status Date
            1979-08-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            55
            Submission Status
            AP
            Submission Status Date
            1979-11-29 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            56
            Submission Status
            AP
            Submission Status Date
            1979-11-29 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            57
            Submission Status
            AP
            Submission Status Date
            1979-12-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            58
            Submission Status
            AP
            Submission Status Date
            1979-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            59
            Submission Status
            AP
            Submission Status Date
            1979-12-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            60
            Submission Status
            AP
            Submission Status Date
            1979-12-12 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            61
            Submission Status
            AP
            Submission Status Date
            1980-01-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            017362
            Review Priority
            Submission Class Code ID
            3
            Submission No
            63
            Submission Status
            AP
            Submission Status Date
            1980-02-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA017362
          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
          2018-08-21
          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
            017362
            Application Docs Date
            2018-08-24 00:00:00
            Application Docs ID
            55298
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            111
            Submission Type
            SUPPL
          official application record
          Appl No
          017362
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          ACTAVIS LABS UT INC
          openfda application present
          true
          products
          1. Active Ingredient
            PROGESTERONE
            Appl No
            017362
            Drug Name
            PROGESTERONE
            Form
            INJECTABLE;INJECTION
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
            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. NDA017362
        brand names
        1. PROGESTERONE
        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
        197
        end exclusive
        true
        exact text
        INDICATIONS AND USAGE This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
        label id
        aacccc63-aa7d-435e-bec5-0aab0e04153f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b5844a145abe89e6667a68fc781103419384859056d837641fbdcf75511f06cf
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-71f30c1a70a027ab3716
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. PROGESTERONE
        id
        ind-span-b2a66a2baccb58f9da89
        label id
        aacccc63-aa7d-435e-bec5-0aab0e04153f
        positive predicate support span
        end
        44
        end exclusive
        true
        exact text
        is indicated
        label id
        aacccc63-aa7d-435e-bec5-0aab0e04153f
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b5844a145abe89e6667a68fc781103419384859056d837641fbdcf75511f06cf
        start
        32
        qualifier mentions
          regulatory links
            schema version
            0.1.0
            source batch sha256
            424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
            source defined aliases
              source span
              end
              197
              end exclusive
              true
              exact text
              INDICATIONS AND USAGE This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
              label id
              aacccc63-aa7d-435e-bec5-0aab0e04153f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              b5844a145abe89e6667a68fc781103419384859056d837641fbdcf75511f06cf
              start
              0
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%22aacccc63-aa7d-435e-bec5-0aab0e04153f%22
              spl effective date
              2022-10-05
              spl set id
              a09a3b76-36f1-4d20-930e-7e3da97e7ebd
              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

              Preserved source evidence · Not medical advice