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

LABELS · 5a6f698f-5b0a-94f1-e063-6394a90a5d4b

MOVANTIK

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
2026-09-01
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE MOVANTIK ® 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. MOVANTIK is an opioid antagonist 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. (1)
Full extracted label fields
application numbers
  1. NDA204760
boxed warning exact
    brand names
    1. MOVANTIK
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=28596788-b73f-4247-85fc-3105f51fff5a
    generic names
    1. NALOXEGOL OXALATE
    id
    5a6f698f-5b0a-94f1-e063-6394a90a5d4b
    indications and usage exact
    1. 1 INDICATIONS AND USAGE MOVANTIK ® 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. MOVANTIK is an opioid antagonist 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. (1)
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Averitas Pharma, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 82625-8801-1
      2. 82625-8801-2
      3. 82625-8801-3
      4. 82625-8801-4
      5. 82625-8802-1
      6. 82625-8802-2
      7. 82625-8802-3
      8. 82625-8802-4
      product ndcs
      1. 82625-8801
      2. 82625-8802
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00300.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
          300
          total
          830
          sha256
          bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
          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=300&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%225a6f698f-5b0a-94f1-e063-6394a90a5d4b%22
          spl effective date
          2026-09-01
          spl effective time
          20260901
          spl set id
          28596788-b73f-4247-85fc-3105f51fff5a
          spl version
          5
          substance names
          1. NALOXEGOL OXALATE
          uniis
          1. 65I14TNM33
          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
            NDA204760
            payload
            all indexed label documents
            1. Appl No
              204760
              Application Docs Date
              2014-09-19 00:00:00
              Application Docs ID
              19592
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            2. Appl No
              204760
              Application Docs Date
              2016-07-25 00:00:00
              Application Docs ID
              19593
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              SUPPL
            3. Appl No
              204760
              Application Docs Date
              2016-08-23 00:00:00
              Application Docs ID
              45112
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              2
              Submission Type
              SUPPL
            4. Appl No
              204760
              Application Docs Date
              2016-08-23 00:00:00
              Application Docs ID
              45113
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              3
              Submission Type
              SUPPL
            5. Appl No
              204760
              Application Docs Date
              2017-08-03 00:00:00
              Application Docs ID
              49223
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              5
              Submission Type
              SUPPL
            6. Appl No
              204760
              Application Docs Date
              2018-03-02 00:00:00
              Application Docs ID
              52798
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              7
              Submission Type
              SUPPL
            7. Appl No
              204760
              Application Docs Date
              2019-05-30 00:00:00
              Application Docs ID
              58889
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              8
              Submission Type
              SUPPL
            8. Appl No
              204760
              Application Docs Date
              2020-04-14 00:00:00
              Application Docs ID
              62554
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              9
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              204760
              Review Priority
              STANDARD
              Submission Class Code ID
              7
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2014-09-16 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              204760
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2016-07-22 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              204760
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              2
              Submission Status
              AP
              Submission Status Date
              2016-08-22 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              204760
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              3
              Submission Status
              AP
              Submission Status Date
              2016-08-22 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              204760
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              5
              Submission Status
              AP
              Submission Status Date
              2017-08-01 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              204760
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              7
              Submission Status
              AP
              Submission Status Date
              2018-02-28 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              204760
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              8
              Submission Status
              AP
              Submission Status Date
              2019-05-29 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            8. Appl No
              204760
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              9
              Submission Status
              AP
              Submission Status Date
              2020-04-13 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA204760
            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
            2020-04-13
            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
              204760
              Application Docs Date
              2020-04-14 00:00:00
              Application Docs ID
              62554
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              9
              Submission Type
              SUPPL
            official application record
            Appl No
            204760
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            AVERITAS
            openfda application present
            true
            products
            1. Active Ingredient
              NALOXEGOL OXALATE
              Appl No
              204760
              Drug Name
              MOVANTIK
              Form
              TABLET;ORAL
              Product No
              001
              Reference Drug
              1
              Reference Standard
              0
              Strength
              EQ 12.5MG BASE
              marketing status
              1. Prescription
            2. Active Ingredient
              NALOXEGOL OXALATE
              Appl No
              204760
              Drug Name
              MOVANTIK
              Form
              TABLET;ORAL
              Product No
              002
              Reference Drug
              1
              Reference Standard
              1
              Strength
              EQ 25MG 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. NDA204760
          brand names
          1. MOVANTIK
          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
          497
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE MOVANTIK ® 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. MOVANTIK is an opioid antagonist 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
          label id
          5a6f698f-5b0a-94f1-e063-6394a90a5d4b
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          a943900ee2edc56857e3861c498b491218b5f8e96c9d8d7dabf19738e630f052
          start
          0
          current approval status
          not_reconciled
          duplicate text group
          dup-111ff1829f4bfbad4e77
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. NALOXEGOL OXALATE
          id
          ind-span-b16d25775d1180608f56
          label id
          5a6f698f-5b0a-94f1-e063-6394a90a5d4b
          positive predicate support span
          end
          47
          end exclusive
          true
          exact text
          is indicated
          label id
          5a6f698f-5b0a-94f1-e063-6394a90a5d4b
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          a943900ee2edc56857e3861c498b491218b5f8e96c9d8d7dabf19738e630f052
          start
          35
          qualifier mentions
          1. context exact
            d for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chron
            kind
            age
            polarity
            not_inferred
            span
            end
            120
            end exclusive
            true
            exact text
            adult patients
            label id
            5a6f698f-5b0a-94f1-e063-6394a90a5d4b
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            a943900ee2edc56857e3861c498b491218b5f8e96c9d8d7dabf19738e630f052
            start
            106
          regulatory links
            schema version
            0.1.0
            source batch sha256
            bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
            source defined aliases
              source span
              end
              297
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE MOVANTIK ® 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.
              label id
              5a6f698f-5b0a-94f1-e063-6394a90a5d4b
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              a943900ee2edc56857e3861c498b491218b5f8e96c9d8d7dabf19738e630f052
              start
              0
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%225a6f698f-5b0a-94f1-e063-6394a90a5d4b%22
              spl effective date
              2026-09-01
              spl set id
              28596788-b73f-4247-85fc-3105f51fff5a
              spl version
              5
              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
              supportive_care_candidate
              Passage 2 · positive indication candidate
              application numbers
              1. NDA204760
              brand names
              1. MOVANTIK
              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
              594
              end exclusive
              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. MOVANTIK is an opioid antagonist 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. (1)
              label id
              5a6f698f-5b0a-94f1-e063-6394a90a5d4b
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              a943900ee2edc56857e3861c498b491218b5f8e96c9d8d7dabf19738e630f052
              start
              98
              current approval status
              not_reconciled
              duplicate text group
              dup-616be47d309c664ad949
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. NALOXEGOL OXALATE
              id
              ind-span-85160456c8b2f4185239
              label id
              5a6f698f-5b0a-94f1-e063-6394a90a5d4b
              positive predicate support span
              end
              340
              end exclusive
              true
              exact text
              is an opioid antagonist indicated
              label id
              5a6f698f-5b0a-94f1-e063-6394a90a5d4b
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              a943900ee2edc56857e3861c498b491218b5f8e96c9d8d7dabf19738e630f052
              start
              307
              qualifier mentions
              1. context exact
                d for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chron
                kind
                age
                polarity
                not_inferred
                span
                end
                413
                end exclusive
                true
                exact text
                adult patients
                label id
                5a6f698f-5b0a-94f1-e063-6394a90a5d4b
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                a943900ee2edc56857e3861c498b491218b5f8e96c9d8d7dabf19738e630f052
                start
                399
              regulatory links
                schema version
                0.1.0
                source batch sha256
                bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                source defined aliases
                  source span
                  end
                  590
                  end exclusive
                  true
                  exact text
                  MOVANTIK is an opioid antagonist 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.
                  label id
                  5a6f698f-5b0a-94f1-e063-6394a90a5d4b
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  a943900ee2edc56857e3861c498b491218b5f8e96c9d8d7dabf19738e630f052
                  start
                  298
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%225a6f698f-5b0a-94f1-e063-6394a90a5d4b%22
                  spl effective date
                  2026-09-01
                  spl set id
                  28596788-b73f-4247-85fc-3105f51fff5a
                  spl version
                  5
                  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
                  supportive_care_candidate
                  Passage 3 · unclassified context
                  application numbers
                  1. NDA204760
                  brand names
                  1. MOVANTIK
                  classification reasons
                  1. no_unambiguous_positive_indication_predicate
                  clinical review status
                  pending
                  content role
                  unclassified_context
                  context span
                  end
                  594
                  end exclusive
                  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. (1)
                  label id
                  5a6f698f-5b0a-94f1-e063-6394a90a5d4b
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  a943900ee2edc56857e3861c498b491218b5f8e96c9d8d7dabf19738e630f052
                  start
                  391
                  current approval status
                  not_reconciled
                  duplicate text group
                  dup-24bf600b196e278bad64
                  extraction review status
                  automated_candidate_pending_source_review
                  generic names
                  1. NALOXEGOL OXALATE
                  id
                  ind-span-7dbd44b68d440a54cba1
                  label id
                  5a6f698f-5b0a-94f1-e063-6394a90a5d4b
                  positive predicate support span
                  Source null
                  qualifier mentions
                    regulatory links
                      schema version
                      0.1.0
                      source batch sha256
                      bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                      source defined aliases
                        source span
                        end
                        594
                        end exclusive
                        true
                        exact text
                        (1)
                        label id
                        5a6f698f-5b0a-94f1-e063-6394a90a5d4b
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        a943900ee2edc56857e3861c498b491218b5f8e96c9d8d7dabf19738e630f052
                        start
                        591
                        source url
                        https://api.fda.gov/drug/label.json?search=id%3A%225a6f698f-5b0a-94f1-e063-6394a90a5d4b%22
                        spl effective date
                        2026-09-01
                        spl set id
                        28596788-b73f-4247-85fc-3105f51fff5a
                        spl version
                        5
                        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