FDA label
What is Brixadi used for?
Brixadi 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: “BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.”
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Brixadi, injection
Indications and Usage, quoted from the label by Braeburn Inc. (NDA210136). Cross-references to other label sections are left out.
BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.
BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Source: DailyMed label, set id 5d8a8fd0-8619-422a-a664-d1d2e8970f48, version 6, effective December 31, 2025. NDC 58284-208, one of 7 listings for this product.
Questions
What is Brixadi used for?
The FDA label says: “BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.”
What drug class is Brixadi?
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 Brixadi
- Is Brixadi a controlled substance?Schedule III
- Generic for BrixadiFDA Orange Book
- What is Buprenorphine used for?FDA label uses
- Is Buprenorphine a controlled substance?Schedule III
- Generic for ButransFDA Orange Book
- Generic for BelbucaFDA Orange Book
- Generic for BuprenexFDA Orange Book
- Generic for SublocadeFDA Orange Book
- Generic for SubutexFDA Orange Book
- Partial Opioid Agonists listFDA drug class
- NDC 58284-208Brixadi NDC record
- NDC 58284-216Brixadi NDC record
- NDC 58284-224Brixadi NDC record
- Schedule III drugs listDEA schedule