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LABELS · 4911bf7f-0c0c-fde7-e063-6394a90ac636

Pilocarpine hydrochloride

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
2026-01-23
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE Pilocarpine Hydrochloride Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
Full extracted label fields
application numbers
  1. NDA020237
boxed warning exact
    brand names
    1. Pilocarpine hydrochloride
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f950741-fd3f-4bf7-83b0-f5aa9dbceb76
    generic names
    1. PILOCARPINE HYDROCHLORIDE
    id
    4911bf7f-0c0c-fde7-e063-6394a90ac636
    indications and usage exact
    1. INDICATIONS AND USAGE Pilocarpine Hydrochloride Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
    indications and usage tables exact
      is original packager
        manufacturer names
        1. American Health Packaging
        matched search terms
        1. cancer
        package ndcs
        1. 68084-928-95
        2. 68084-928-25
        product ndcs
        1. 68084-928
        product types
        1. HUMAN PRESCRIPTION DRUG
        recent major changes exact
          record type
          complete_spl_indications_section_candidate
          routes
          1. ORAL
          rxcuis
          1. 1000913
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00200.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
          200
          total
          830
          sha256
          d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
          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=200&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%224911bf7f-0c0c-fde7-e063-6394a90ac636%22
          spl effective date
          2026-01-23
          spl effective time
          20260123
          spl set id
          6f950741-fd3f-4bf7-83b0-f5aa9dbceb76
          spl version
          8
          substance names
          1. PILOCARPINE HYDROCHLORIDE
          uniis
          1. 0WW6D218XJ
          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. not_identified_as_original_packager
          Drugs@FDA application source records
          1. application number
            NDA020237
            payload
            all indexed label documents
            1. Appl No
              020237
              Application Docs Date
              2002-06-10 00:00:00
              Application Docs ID
              12350
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              9
              Submission Type
              SUPPL
            2. Appl No
              020237
              Application Docs Date
              2003-04-28 00:00:00
              Application Docs ID
              12351
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              12
              Submission Type
              SUPPL
            3. Appl No
              020237
              Application Docs Date
              2002-06-10 00:00:00
              Application Docs ID
              34410
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              8
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              020237
              Review Priority
              PRIORITY
              Submission Class Code ID
              12
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              1994-03-22 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              020237
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              1996-04-18 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              020237
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              2
              Submission Status
              AP
              Submission Status Date
              1995-11-09 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              020237
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              3
              Submission Status
              AP
              Submission Status Date
              1995-11-09 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              020237
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              4
              Submission Status
              AP
              Submission Status Date
              1995-11-09 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              020237
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              5
              Submission Status
              AP
              Submission Status Date
              1996-09-27 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              020237
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              6
              Submission Status
              AP
              Submission Status Date
              1997-03-11 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            8. Appl No
              020237
              Review Priority
              STANDARD
              Submission Class Code ID
              2
              Submission No
              7
              Submission Status
              AP
              Submission Status Date
              1998-02-11 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            9. Appl No
              020237
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              8
              Submission Status
              AP
              Submission Status Date
              2002-06-10 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            10. Appl No
              020237
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              9
              Submission Status
              AP
              Submission Status Date
              2002-06-10 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            11. Appl No
              020237
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              10
              Submission Status
              AP
              Submission Status Date
              2000-02-04 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            12. Appl No
              020237
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              11
              Submission Status
              AP
              Submission Status Date
              2002-09-04 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA020237
            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
            2015-09-10
            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
              020237
              Application Docs Date
              2003-04-28 00:00:00
              Application Docs ID
              12351
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              12
              Submission Type
              SUPPL
            official application record
            Appl No
            020237
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            ADVANZ PHARMA
            openfda application present
            true
            products
            1. Active Ingredient
              PILOCARPINE HYDROCHLORIDE
              Appl No
              020237
              Drug Name
              SALAGEN
              Form
              TABLET;ORAL
              Product No
              001
              Reference Drug
              1
              Reference Standard
              0
              Strength
              5MG
              marketing status
              1. Prescription
            2. Active Ingredient
              PILOCARPINE HYDROCHLORIDE
              Appl No
              020237
              Drug Name
              SALAGEN
              Form
              TABLET;ORAL
              Product No
              002
              Reference Drug
              1
              Reference Standard
              1
              Strength
              7.5MG
              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. NDA020237
          brand names
          1. Pilocarpine hydrochloride
          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
          287
          end exclusive
          true
          exact text
          INDICATIONS AND USAGE Pilocarpine Hydrochloride Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
          label id
          4911bf7f-0c0c-fde7-e063-6394a90ac636
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          6bc38d241245f76cb1d3a9dcea408d5c954d0634e87e28fb2f7a3cd3bc192718
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-0edbd6df4bc1f9b5dd8d
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. PILOCARPINE HYDROCHLORIDE
          id
          ind-span-223666fe6c765c00005a
          label id
          4911bf7f-0c0c-fde7-e063-6394a90ac636
          positive predicate support span
          end
          69
          end exclusive
          true
          exact text
          are indicated
          label id
          4911bf7f-0c0c-fde7-e063-6394a90ac636
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          6bc38d241245f76cb1d3a9dcea408d5c954d0634e87e28fb2f7a3cd3bc192718
          start
          56
          qualifier mentions
            regulatory links
              schema version
              0.1.0
              source batch sha256
              d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
              source defined aliases
                source span
                end
                287
                end exclusive
                true
                exact text
                INDICATIONS AND USAGE Pilocarpine Hydrochloride Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
                label id
                4911bf7f-0c0c-fde7-e063-6394a90ac636
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                6bc38d241245f76cb1d3a9dcea408d5c954d0634e87e28fb2f7a3cd3bc192718
                start
                0
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%224911bf7f-0c0c-fde7-e063-6394a90ac636%22
                spl effective date
                2026-01-23
                spl set id
                6f950741-fd3f-4bf7-83b0-f5aa9dbceb76
                spl version
                8
                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