FDA label
What is buprenorphine used for?
The FDA-approved uses of buprenorphine, 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: “Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and is preferred for induction.”
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Buprenorphine Hydrochloride, tablet
Indications and Usage, quoted from the label by Advagen Pharma Ltd (ANDA090279). Cross-references to other label sections are left out.
Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and is preferred for induction.
Source: DailyMed label, set id 699638dd-3a53-445f-a545-d0e6eabfe1c9, version 7, effective July 17, 2026. NDC 72888-182, one of 51 listings for this product.
Buprenorphine, patch, extended release
Indications and Usage, quoted from the label by Teva Pharmaceuticals USA, Inc. (ANDA204937). Cross-references to other label sections are left out.
Buprenorphine transdermal system 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.
L imitations 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 buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic
Source: DailyMed label, set id 36995ce3-b515-447b-baa9-aa14f84060d8, version 21, effective May 12, 2026. NDC 0093-3239, one of 25 listings for this product.
Buprenorphine Hydrochloride, injection
Indications and Usage, quoted from the label by Gland Pharma Limited (ANDA221145). Cross-references to other label sections are left out.
Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. 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 buprenorphine, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id 69ec3405-78ee-4cb4-9180-9bea937a8dcd, version 4, effective October 16, 2026. NDC 68083-696, one of 4 listings for this product.
Questions
What is buprenorphine used for?
The FDA label says: “Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and is preferred for induction.”
What drug class is buprenorphine?
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.
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