FDA label
What is Sublocade used for?
Sublocade 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: “SUBLOCADE 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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Indications and Usage, quoted from the label by Indivior Inc. (NDA209819). Cross-references to other label sections are left out.
SUBLOCADE 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.
SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Source: DailyMed label, set id 6189fb21-9432-45f8-8481-0bfaf3ccde95, version 43, effective July 27, 2026. NDC 12496-0100, one of 2 listings for this product.
Questions
What is Sublocade used for?
The FDA label says: “SUBLOCADE 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 Sublocade?
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 Sublocade
- Is Sublocade a controlled substance?Schedule III
- Generic for SublocadeFDA 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 BrixadiFDA Orange Book
- Generic for SubutexFDA Orange Book
- Partial Opioid Agonists listFDA drug class
- NDC 12496-0100Sublocade NDC record
- NDC 12496-0300Sublocade NDC record
- Schedule III drugs listDEA schedule