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LABELS · 979b0a0c-7868-4ec1-8887-f2b7e43f4326

PROSCAR

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
2026-03-18
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE PROSCAR, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ). Limitations of Use : PROSCAR is not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy PROSCAR ® is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - Improve symptoms - Reduce the risk of acute urinary retention - Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. 1.2 Combination with Alpha-Blocker PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score). 1.3 Limitations of Use PROSCAR is not approved for the prevention of prostate cancer.
Full extracted label fields
application numbers
  1. NDA020180
boxed warning exact
    brand names
    1. PROSCAR
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b
    generic names
    1. FINASTERIDE
    id
    979b0a0c-7868-4ec1-8887-f2b7e43f4326
    indications and usage exact
    1. 1 INDICATIONS AND USAGE PROSCAR, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ). Limitations of Use : PROSCAR is not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy PROSCAR ® is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - Improve symptoms - Reduce the risk of acute urinary retention - Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. 1.2 Combination with Alpha-Blocker PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score). 1.3 Limitations of Use PROSCAR is not approved for the prevention of prostate cancer.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Organon LLC
      matched search terms
      1. cancer
      package ndcs
      1. 78206-153-01
      2. 78206-153-02
      product ndcs
      1. 78206-153
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 201961
        2. 310346
        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
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        url
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        source url
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        spl effective date
        2026-03-18
        spl effective time
        20260318
        spl set id
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        spl version
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        substance names
        1. FINASTERIDE
        uniis
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        verification flags
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        Drugs@FDA application source records
        1. application number
          NDA020180
          payload
          all indexed label documents
          1. Appl No
            020180
            Application Docs Date
            2004-04-14 00:00:00
            Application Docs ID
            12298
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            26
            Submission Type
            SUPPL
          2. Appl No
            020180
            Application Docs Date
            2010-10-04 00:00:00
            Application Docs ID
            12299
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            37
            Submission Type
            SUPPL
          3. Appl No
            020180
            Application Docs Date
            2012-04-11 00:00:00
            Application Docs ID
            12300
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            41
            Submission Type
            SUPPL
          4. Appl No
            020180
            Application Docs Date
            2014-03-13 00:00:00
            Application Docs ID
            12301
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            44
            Submission Type
            SUPPL
          5. Appl No
            020180
            Application Docs Date
            2003-09-25 00:00:00
            Application Docs ID
            34342
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            27
            Submission Type
            SUPPL
          6. Appl No
            020180
            Application Docs Date
            2004-05-04 00:00:00
            Application Docs ID
            34343
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            29
            Submission Type
            SUPPL
          7. Appl No
            020180
            Application Docs Date
            2010-03-26 00:00:00
            Application Docs ID
            34344
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            33
            Submission Type
            SUPPL
          8. Appl No
            020180
            Application Docs Date
            2011-06-10 00:00:00
            Application Docs ID
            34345
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            39
            Submission Type
            SUPPL
          9. Appl No
            020180
            Application Docs Date
            2012-04-11 00:00:00
            Application Docs ID
            34346
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            40
            Submission Type
            SUPPL
          10. Appl No
            020180
            Application Docs Date
            2012-04-11 00:00:00
            Application Docs ID
            34347
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            42
            Submission Type
            SUPPL
          11. Appl No
            020180
            Application Docs Date
            2013-01-22 00:00:00
            Application Docs ID
            34348
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            43
            Submission Type
            SUPPL
          12. Appl No
            020180
            Application Docs Date
            2021-04-16 00:00:00
            Application Docs ID
            67071
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            48
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            020180
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            50
            Submission Status
            AP
            Submission Status Date
            2026-03-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            020180
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            49
            Submission Status
            AP
            Submission Status Date
            2021-08-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            020180
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            48
            Submission Status
            AP
            Submission Status Date
            2021-04-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            020180
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            47
            Submission Status
            AP
            Submission Status Date
            2021-06-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            020180
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            45
            Submission Status
            AP
            Submission Status Date
            2015-07-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            020180
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            44
            Submission Status
            AP
            Submission Status Date
            2014-03-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            020180
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            43
            Submission Status
            AP
            Submission Status Date
            2013-01-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            020180
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            42
            Submission Status
            AP
            Submission Status Date
            2012-04-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            020180
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            41
            Submission Status
            AP
            Submission Status Date
            2012-04-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            020180
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            40
            Submission Status
            AP
            Submission Status Date
            2012-04-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            020180
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            39
            Submission Status
            AP
            Submission Status Date
            2011-06-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            020180
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            37
            Submission Status
            AP
            Submission Status Date
            2010-10-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA020180
          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
          2026-03-18
          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
            020180
            Application Docs Date
            2026-03-24 00:00:00
            Application Docs ID
            85482
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            50
            Submission Type
            SUPPL
          official application record
          Appl No
          020180
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          ORGANON
          openfda application present
          true
          products
          1. Active Ingredient
            FINASTERIDE
            Appl No
            020180
            Drug Name
            PROSCAR
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            5MG
            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. NDA020180
        brand names
        1. PROSCAR
        classification reasons
        1. explicit_positive_indication_predicate
        2. no_tumor_directed_keyword_in_positive_statement
        3. positive_statement_also_contains_qualification_review_required
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        560
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE PROSCAR, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Associatio
        label id
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        offset unit
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        source text sha256
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        not_reconciled
        duplicate text group
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        generic names
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        id
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        label id
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        positive predicate support span
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        true
        exact text
        is a 5α-reductase inhibitor, indicated
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        qualifier mentions
        1. context exact
          ( 1.1 ): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TU
          kind
          biomarker
          polarity
          not_inferred
          span
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          exact text
          retention Reduce the risk of the need for s
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          source defined aliases
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            exact text
            1 INDICATIONS AND USAGE PROSCAR, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
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            spl effective date
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            spl set id
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            structured fields status
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            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
            non_oncology_or_unclear_candidate
            Passage 2 · positive indication candidate
            application numbers
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            clinical review status
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            791
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            true
            exact text
            ed prostate to ( 1.1 ): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ). Limitations of Use : PROSCAR is not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy PROSCAR ® is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH)
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            qualifier mentions
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              PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ).
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                PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ).
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                source url
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                spl effective date
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                structured fields status
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                Source null
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                Source null
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                Source null
                limitations
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                Source null
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                application numbers
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                exact text
                tion with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ). Limitations of Use : PROSCAR is not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy PROSCAR ® is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - Improve symptoms - Reduce the risk of acute urinary r
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                      sion of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ). Limitations of Use : PROSCAR is not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy PROSCAR ® is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - Improve symptoms - Reduce the risk of acute urinary retention - Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. 1.2 Combination with Alpha-Blocker PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increas
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                          1.1 Monotherapy PROSCAR ® is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - Improve symptoms - Reduce the risk of acute urinary retention - Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
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                                    Preserved source evidence · Not medical advice