FDA label
What is Suboxone used for?
Suboxone contains buprenorphine and naloxone. 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: “SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.”
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Suboxone, film, soluble
Indications and Usage, quoted from the label by INDIVIOR INC. (NDA022410). Cross-references to other label sections are left out.
SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Source: DailyMed label, set id 8a5edcf9-828c-4f97-b671-268ab13a8ecd, version 37, effective December 22, 2025. NDC 12496-1202, one of 4 listings for this product.
Questions
What is Suboxone used for?
The FDA label says: “SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.”
What drug class is Suboxone?
FDA lists buprenorphine and naloxone in the Opioid Antagonist and 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 Suboxone
- Is Suboxone a controlled substance?Schedule III
- Generic for SuboxoneFDA Orange Book
- What is Buprenorphine and Naloxone used for?FDA label uses
- Is Buprenorphine and Naloxone a controlled substance?Schedule III
- Generic for ZubsolvFDA Orange Book
- Opioid Antagonists listFDA drug class
- Partial Opioid Agonists listFDA drug class
- Suboxone Medicare Part D coverageBy plan and state
- NDC 12496-1202Suboxone NDC record
- NDC 12496-1204Suboxone NDC record
- NDC 12496-1208Suboxone NDC record
- Schedule III drugs listDEA schedule