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

LABELS · 7ce44be3-47a7-411e-ad1f-a2efc4916425

SYMPROIC

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
2025-07-25
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE SYMPROIC 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. SYMPROIC 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. NDA208854
boxed warning exact
    brand names
    1. SYMPROIC
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b1a1256c-a1eb-4abe-ab1e-30e4711afd16
    generic names
    1. NALDEMEDINE
    id
    7ce44be3-47a7-411e-ad1f-a2efc4916425
    indications and usage exact
    1. 1 INDICATIONS AND USAGE SYMPROIC 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. SYMPROIC 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. BioDelivery Sciences International Inc
      matched search terms
      1. cancer
      package ndcs
      1. 59385-041-30
      2. 59385-041-07
      product ndcs
      1. 59385-041
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Gastrointestinal Perforation ( 5.1 ) 07/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1876603
      2. 1876609
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00400.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
      400
      total
      830
      sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      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=400&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%227ce44be3-47a7-411e-ad1f-a2efc4916425%22
      spl effective date
      2025-07-25
      spl effective time
      20250725
      spl set id
      b1a1256c-a1eb-4abe-ab1e-30e4711afd16
      spl version
      10
      substance names
      1. NALDEMEDINE TOSYLATE
      uniis
      1. V1N8F1RVVO
      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
        NDA208854
        payload
        all indexed label documents
        1. Appl No
          208854
          Application Docs Date
          2017-03-24 00:00:00
          Application Docs ID
          47697
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          208854
          Application Docs Date
          2017-08-02 00:00:00
          Application Docs ID
          49203
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          208854
          Application Docs Date
          2018-01-26 00:00:00
          Application Docs ID
          51911
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          208854
          Application Docs Date
          2025-07-21 00:00:00
          Application Docs ID
          82893
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          208854
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2017-03-23 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          208854
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2017-08-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          208854
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2018-01-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          208854
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2025-07-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA208854
        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
        2025-07-15
        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
          208854
          Application Docs Date
          2025-07-21 00:00:00
          Application Docs ID
          82893
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        official application record
        Appl No
        208854
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        BDSI
        openfda application present
        true
        products
        1. Active Ingredient
          NALDEMEDINE TOSYLATE
          Appl No
          208854
          Drug Name
          SYMPROIC
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 0.2MG 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. NDA208854
      brand names
      1. SYMPROIC
      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
      495
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE SYMPROIC 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. SYMPROIC 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
      7ce44be3-47a7-411e-ad1f-a2efc4916425
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      40d53446ba8313b1aa7da65c4540d226ae94a710e371ae91046e41179423d9a6
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-ef0598bcbdaeabf530ff
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. NALDEMEDINE
      id
      ind-span-6dbda514442bccf8b5ec
      label id
      7ce44be3-47a7-411e-ad1f-a2efc4916425
      positive predicate support span
      end
      45
      end exclusive
      true
      exact text
      is indicated
      label id
      7ce44be3-47a7-411e-ad1f-a2efc4916425
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      40d53446ba8313b1aa7da65c4540d226ae94a710e371ae91046e41179423d9a6
      start
      33
      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
        118
        end exclusive
        true
        exact text
        adult patients
        label id
        7ce44be3-47a7-411e-ad1f-a2efc4916425
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        40d53446ba8313b1aa7da65c4540d226ae94a710e371ae91046e41179423d9a6
        start
        104
      regulatory links
        schema version
        0.1.0
        source batch sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        source defined aliases
          source span
          end
          295
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE SYMPROIC 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
          7ce44be3-47a7-411e-ad1f-a2efc4916425
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          40d53446ba8313b1aa7da65c4540d226ae94a710e371ae91046e41179423d9a6
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%227ce44be3-47a7-411e-ad1f-a2efc4916425%22
          spl effective date
          2025-07-25
          spl set id
          b1a1256c-a1eb-4abe-ab1e-30e4711afd16
          spl version
          10
          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. NDA208854
          brand names
          1. SYMPROIC
          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
          593
          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. SYMPROIC 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
          7ce44be3-47a7-411e-ad1f-a2efc4916425
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          40d53446ba8313b1aa7da65c4540d226ae94a710e371ae91046e41179423d9a6
          start
          96
          current approval status
          not_reconciled
          duplicate text group
          dup-bd6ead6c4be070ce6172
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. NALDEMEDINE
          id
          ind-span-4ee0760e288045a18d2f
          label id
          7ce44be3-47a7-411e-ad1f-a2efc4916425
          positive predicate support span
          end
          338
          end exclusive
          true
          exact text
          is an opioid antagonist indicated
          label id
          7ce44be3-47a7-411e-ad1f-a2efc4916425
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          40d53446ba8313b1aa7da65c4540d226ae94a710e371ae91046e41179423d9a6
          start
          305
          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
            411
            end exclusive
            true
            exact text
            adult patients
            label id
            7ce44be3-47a7-411e-ad1f-a2efc4916425
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            40d53446ba8313b1aa7da65c4540d226ae94a710e371ae91046e41179423d9a6
            start
            397
          regulatory links
            schema version
            0.1.0
            source batch sha256
            a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
            source defined aliases
              source span
              end
              593
              end exclusive
              true
              exact text
              SYMPROIC 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
              7ce44be3-47a7-411e-ad1f-a2efc4916425
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              40d53446ba8313b1aa7da65c4540d226ae94a710e371ae91046e41179423d9a6
              start
              296
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%227ce44be3-47a7-411e-ad1f-a2efc4916425%22
              spl effective date
              2025-07-25
              spl set id
              b1a1256c-a1eb-4abe-ab1e-30e4711afd16
              spl version
              10
              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

              Preserved source evidence · Not medical advice