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LABELS · 2bd6f613-64d1-0291-e063-6294a90a0238

Lubiprostone

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
2025-01-16
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1.1 Chronic Idiopathic Constipation in Adults Lubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain Lubiprostone is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Limitations of Use: Effectiveness of Lubiprostone in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see Clinical Studies (14.2)] 1.3 Irritable Bowel Syndrome with Constipation Lubiprostone is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.
Full extracted label fields
application numbers
  1. NDA021908
boxed warning exact
    brand names
    1. Lubiprostone
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2bd6f613-64d0-0291-e063-6294a90a0238
    generic names
    1. LUBIPROSTONE
    id
    2bd6f613-64d1-0291-e063-6294a90a0238
    indications and usage exact
    1. 1.1 Chronic Idiopathic Constipation in Adults Lubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain Lubiprostone is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Limitations of Use: Effectiveness of Lubiprostone in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see Clinical Studies (14.2)] 1.3 Irritable Bowel Syndrome with Constipation Lubiprostone is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.
    indications and usage tables exact
      is original packager
        manufacturer names
        1. Direct Rx
        matched search terms
        1. cancer
        package ndcs
        1. 72189-607-60
        product ndcs
        1. 72189-607
        product types
        1. HUMAN PRESCRIPTION DRUG
        recent major changes exact
          record type
          complete_spl_indications_section_candidate
          routes
          1. ORAL
          rxcuis
          1. 616578
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00100.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
          100
          total
          830
          sha256
          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
          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=100&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%222bd6f613-64d1-0291-e063-6294a90a0238%22
          spl effective date
          2025-01-16
          spl effective time
          20250116
          spl set id
          2bd6f613-64d0-0291-e063-6294a90a0238
          spl version
          1
          substance names
          1. LUBIPROSTONE
          uniis
          1. 7662KG2R6K
          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
            NDA021908
            payload
            all indexed label documents
            1. Appl No
              021908
              Application Docs Date
              2008-05-02 00:00:00
              Application Docs ID
              16555
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              5
              Submission Type
              SUPPL
            2. Appl No
              021908
              Application Docs Date
              2011-03-04 00:00:00
              Application Docs ID
              16556
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              8
              Submission Type
              SUPPL
            3. Appl No
              021908
              Application Docs Date
              2012-11-26 00:00:00
              Application Docs ID
              16557
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              10
              Submission Type
              SUPPL
            4. Appl No
              021908
              Application Docs Date
              2013-04-23 00:00:00
              Application Docs ID
              16558
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              11
              Submission Type
              SUPPL
            5. Appl No
              021908
              Application Docs Date
              2006-02-02 00:00:00
              Application Docs ID
              37863
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            6. Appl No
              021908
              Application Docs Date
              2007-05-29 00:00:00
              Application Docs ID
              37864
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              4
              Submission Type
              SUPPL
            7. Appl No
              021908
              Application Docs Date
              2016-11-01 00:00:00
              Application Docs ID
              45750
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              13
              Submission Type
              SUPPL
            8. Appl No
              021908
              Application Docs Date
              2017-08-02 00:00:00
              Application Docs ID
              49204
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              15
              Submission Type
              SUPPL
            9. Appl No
              021908
              Application Docs Date
              2018-04-27 00:00:00
              Application Docs ID
              53862
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              16
              Submission Type
              SUPPL
            10. Appl No
              021908
              Application Docs Date
              2020-12-04 00:00:00
              Application Docs ID
              65500
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              18
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              021908
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              18
              Submission Status
              AP
              Submission Status Date
              2020-11-30 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            2. Appl No
              021908
              Review Priority
              PRIORITY
              Submission Class Code ID
              2
              Submission No
              16
              Submission Status
              AP
              Submission Status Date
              2018-04-26 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              021908
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              15
              Submission Status
              AP
              Submission Status Date
              2017-08-01 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              021908
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              13
              Submission Status
              AP
              Submission Status Date
              2016-10-11 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              021908
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              12
              Submission Status
              AP
              Submission Status Date
              2013-08-19 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              021908
              Review Priority
              PRIORITY
              Submission Class Code ID
              2
              Submission No
              11
              Submission Status
              AP
              Submission Status Date
              2013-04-19 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              021908
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              10
              Submission Status
              AP
              Submission Status Date
              2012-11-26 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            8. Appl No
              021908
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              8
              Submission Status
              AP
              Submission Status Date
              2011-02-24 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            9. Appl No
              021908
              Review Priority
              UNKNOWN
              Submission Class Code ID
              2
              Submission No
              5
              Submission Status
              AP
              Submission Status Date
              2008-04-29 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            10. Appl No
              021908
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              4
              Submission Status
              AP
              Submission Status Date
              2007-05-16 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            11. Appl No
              021908
              Review Priority
              STANDARD
              Submission Class Code ID
              7
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2006-01-31 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            application number
            NDA021908
            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
            2020-11-30
            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
              021908
              Application Docs Date
              2020-12-04 00:00:00
              Application Docs ID
              65500
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              18
              Submission Type
              SUPPL
            official application record
            Appl No
            021908
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            SUCAMPO PHARMA LLC
            openfda application present
            true
            products
            1. Active Ingredient
              LUBIPROSTONE
              Appl No
              021908
              Drug Name
              AMITIZA
              Form
              CAPSULE;ORAL
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              24MCG
              marketing status
              1. Prescription
            2. Active Ingredient
              LUBIPROSTONE
              Appl No
              021908
              Drug Name
              AMITIZA
              Form
              CAPSULE;ORAL
              Product No
              002
              Reference Drug
              1
              Reference Standard
              0
              Strength
              8MCG
              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. NDA021908
          brand names
          1. Lubiprostone
          classification reasons
          1. explicit_positive_indication_predicate
          2. no_tumor_directed_keyword_in_positive_statement
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          341
          end exclusive
          true
          exact text
          1.1 Chronic Idiopathic Constipation in Adults Lubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain Lubiprostone is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-canc
          label id
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          offset unit
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          source field
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          source text sha256
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          start
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          current approval status
          not_reconciled
          duplicate text group
          dup-a02ec152d8a4bfd2bc28
          extraction review status
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          generic names
          1. LUBIPROSTONE
          id
          ind-span-93ae891c112b304a59d3
          label id
          2bd6f613-64d1-0291-e063-6294a90a0238
          positive predicate support span
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          true
          exact text
          is indicated
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          source text sha256
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          qualifier mentions
          1. context exact
            1.1 Chronic Idiopathic Constipation in Adults Lubiprostone is indicated for the treatment of chronic idio
            kind
            age
            polarity
            not_inferred
            span
            end
            45
            end exclusive
            true
            exact text
            Adults
            label id
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          2. context exact
            r the treatment of chronic idiopathic constipation (CIC) in adults.
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            polarity
            not_inferred
            span
            end
            140
            end exclusive
            true
            exact text
            adults
            label id
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            source field
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          regulatory links
            schema version
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            source batch sha256
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            source defined aliases
              source span
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              141
              end exclusive
              true
              exact text
              1.1 Chronic Idiopathic Constipation in Adults Lubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
              label id
              2bd6f613-64d1-0291-e063-6294a90a0238
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              start
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              source url
              https://api.fda.gov/drug/label.json?search=id%3A%222bd6f613-64d1-0291-e063-6294a90a0238%22
              spl effective date
              2025-01-16
              spl set id
              2bd6f613-64d0-0291-e063-6294a90a0238
              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
              non_oncology_or_unclear_candidate
              Passage 2 · positive indication candidate
              application numbers
              1. NDA021908
              brand names
              1. Lubiprostone
              classification reasons
              1. explicit_positive_indication_predicate
              2. supportive_or_complication_use_words
              clinical review status
              pending
              content role
              positive_indication_candidate
              context span
              end
              696
              end exclusive
              true
              exact text
              1.1 Chronic Idiopathic Constipation in Adults Lubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain Lubiprostone is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Limitations of Use: Effectiveness of Lubiprostone in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see Clinical
              label id
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              duplicate text group
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              1. LUBIPROSTONE
              id
              ind-span-2d5c572fca1410f39b64
              label id
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              positive predicate support span
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              qualifier mentions
              1. context exact
                1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain Lubiprostone is indicated for
                kind
                age
                polarity
                not_inferred
                span
                end
                191
                end exclusive
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                Adult Patients
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              2. context exact
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                not_inferred
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                319
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                adult patients
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              regulatory links
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                source defined aliases
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                  end exclusive
                  true
                  exact text
                  1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain Lubiprostone is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
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                  source url
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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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                  structured indication
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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
                  supportive_care_candidate
                  Passage 3 · limitation of use
                  application numbers
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                  brand names
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                  classification reasons
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                  clinical review status
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                  content role
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                  true
                  exact text
                  OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Limitations of Use: Effectiveness of Lubiprostone in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see Clinical Studies (14.2)] 1.3 Irritable Bowel Syndrome with Constipation Lubiprostone is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.
                  label id
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                  offset unit
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                  current approval status
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                  duplicate text group
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                  extraction review status
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                  generic names
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                  id
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                          Preserved source evidence · Not medical advice