FDA label
What is Belbuca used for?
Belbuca contains buprenorphine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “BELBUCA is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.”
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Belbuca, film, soluble
Indications and Usage, quoted from the label by BioDelivery Sciences International Inc (NDA207932). Cross-references to other label sections are left out.
BELBUCA is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.
Limitations of Use
- Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including BELBUCA, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- BELBUCA is not indicated as an as-needed (prn) analgesic.
Source: DailyMed label, set id bc2b7a3d-72cf-497c-95b0-ba2b71f63c64, version 18, effective January 2, 2026. NDC 59385-021, one of 7 listings for this product.
Questions
What is Belbuca used for?
The FDA label says: “BELBUCA is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.”
What drug class is Belbuca?
FDA lists buprenorphine in the Partial Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Belbuca
- Is Belbuca a controlled substance?Schedule III
- Generic for BelbucaFDA Orange Book
- What is Buprenorphine used for?FDA label uses
- Is Buprenorphine a controlled substance?Schedule III
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- Generic for BuprenexFDA Orange Book
- Generic for BrixadiFDA Orange Book
- Generic for SublocadeFDA Orange Book
- Generic for SubutexFDA Orange Book
- Partial Opioid Agonists listFDA drug class
- NDC 59385-021Belbuca NDC record
- NDC 59385-022Belbuca NDC record
- NDC 59385-023Belbuca NDC record
- Schedule III drugs listDEA schedule