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

LABELS · 3e9075cb-001f-40f0-e063-6394a90aee94

INLEXZO

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
2025-09-11
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )
Full extracted label fields
application numbers
  1. NDA219683
boxed warning exact
    brand names
    1. INLEXZO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb
    generic names
    1. GEMCITABINE INTRAVESICAL
    id
    3e9075cb-001f-40f0-e063-6394a90aee94
    indications and usage exact
    1. 1 INDICATIONS AND USAGE INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Janssen Biotech, Inc
      matched search terms
      1. cancer
      2. carcinoma
      3. tumors
      package ndcs
      1. 57894-225-01
      2. 57894-225-99
      product ndcs
      1. 57894-225
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVESICAL
        rxcuis
        1. 2723386
        2. 2723391
        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%223e9075cb-001f-40f0-e063-6394a90aee94%22
        spl effective date
        2025-09-11
        spl effective time
        20250911
        spl set id
        3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb
        spl version
        1
        substance names
        1. GEMCITABINE
        uniis
        1. B76N6SBZ8R
        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
          NDA219683
          payload
          all indexed label documents
          1. Appl No
            219683
            Application Docs Date
            2025-09-10 00:00:00
            Application Docs ID
            83315
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            219683
            Review Priority
            PRIORITY
            Submission Class Code ID
            12
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-09-09 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          NDA219683
          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
          2025-09-09
          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
            219683
            Application Docs Date
            2025-09-10 00:00:00
            Application Docs ID
            83315
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
          219683
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          JANSSEN BIOTECH
          openfda application present
          true
          products
          1. Active Ingredient
            GEMCITABINE HYDROCHLORIDE
            Appl No
            219683
            Drug Name
            INLEXZO
            Form
            SYSTEM;INTRAVESICAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 225MG BASE
            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. NDA219683
        brand names
        1. INLEXZO
        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
        437
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder
        label id
        3e9075cb-001f-40f0-e063-6394a90aee94
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-e21d8ee9e5d15c2d5ccc
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. GEMCITABINE INTRAVESICAL
        id
        ind-span-44a22729b0b46b0ae55b
        label id
        3e9075cb-001f-40f0-e063-6394a90aee94
        positive predicate support span
        end
        44
        end exclusive
        true
        exact text
        is indicated
        label id
        3e9075cb-001f-40f0-e063-6394a90aee94
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
        start
        32
        qualifier mentions
        1. context exact
          CATIONS AND USAGE INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscl
          kind
          age
          polarity
          not_inferred
          span
          end
          80
          end exclusive
          true
          exact text
          adult patients
          label id
          3e9075cb-001f-40f0-e063-6394a90aee94
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
          start
          66
        2. context exact
          vasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
          kind
          regimen
          polarity
          not_inferred
          span
          end
          236
          end exclusive
          true
          exact text
          with or without papillary tumors
          label id
          3e9075cb-001f-40f0-e063-6394a90aee94
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
          start
          204
        regulatory links
          schema version
          0.1.0
          source batch sha256
          d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
          source defined aliases
            source span
            end
            237
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
            label id
            3e9075cb-001f-40f0-e063-6394a90aee94
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%223e9075cb-001f-40f0-e063-6394a90aee94%22
            spl effective date
            2025-09-11
            spl set id
            3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb
            spl version
            1
            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 · positive indication candidate
            application numbers
            1. NDA219683
            brand names
            1. INLEXZO
            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
            521
            end exclusive
            true
            exact text
            icated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )
            label id
            3e9075cb-001f-40f0-e063-6394a90aee94
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
            start
            38
            current approval status
            not_reconciled
            duplicate text group
            dup-83449e0fbf8ab07a5c7e
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. GEMCITABINE INTRAVESICAL
            id
            ind-span-66397f989bb9c16f4264
            label id
            3e9075cb-001f-40f0-e063-6394a90aee94
            positive predicate support span
            end
            323
            end exclusive
            true
            exact text
            is a nucleoside metabolic inhibitor-containing intravesical system, indicated
            label id
            3e9075cb-001f-40f0-e063-6394a90aee94
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
            start
            246
            qualifier mentions
            1. context exact
              taining intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscl
              kind
              age
              polarity
              not_inferred
              span
              end
              359
              end exclusive
              true
              exact text
              adult patients
              label id
              3e9075cb-001f-40f0-e063-6394a90aee94
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
              start
              345
            2. context exact
              INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with
              kind
              biomarker
              polarity
              not_inferred
              span
              end
              305
              end exclusive
              true
              exact text
              metabolic inhibitor-containing intravesical
              label id
              3e9075cb-001f-40f0-e063-6394a90aee94
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
              start
              262
            3. context exact
              nvasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
              kind
              regimen
              polarity
              not_inferred
              span
              end
              514
              end exclusive
              true
              exact text
              with or without papillary tumors
              label id
              3e9075cb-001f-40f0-e063-6394a90aee94
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
              start
              482
            regulatory links
              schema version
              0.1.0
              source batch sha256
              d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
              source defined aliases
                source span
                end
                515
                end exclusive
                true
                exact text
                INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
                label id
                3e9075cb-001f-40f0-e063-6394a90aee94
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
                start
                238
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%223e9075cb-001f-40f0-e063-6394a90aee94%22
                spl effective date
                2025-09-11
                spl set id
                3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb
                spl version
                1
                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 3 · unclassified context
                application numbers
                1. NDA219683
                brand names
                1. INLEXZO
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                521
                end exclusive
                true
                exact text
                dicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )
                label id
                3e9075cb-001f-40f0-e063-6394a90aee94
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
                start
                316
                current approval status
                not_reconciled
                duplicate text group
                dup-b3b83be78352d93b3121
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. GEMCITABINE INTRAVESICAL
                id
                ind-span-c028bb876253e4c38d56
                label id
                3e9075cb-001f-40f0-e063-6394a90aee94
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                    source defined aliases
                      source span
                      end
                      521
                      end exclusive
                      true
                      exact text
                      ( 1 )
                      label id
                      3e9075cb-001f-40f0-e063-6394a90aee94
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      34e3b0c717a63d965be0323052280e98a3662b5e03a05a0e1edb12a41e6a7370
                      start
                      516
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%223e9075cb-001f-40f0-e063-6394a90aee94%22
                      spl effective date
                      2025-09-11
                      spl set id
                      3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb
                      spl version
                      1
                      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

                      Preserved source evidence · Not medical advice