FDA label
What is Zubsolv used for?
Zubsolv 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: “ZUBSOLV is indicated for treatment of opioid dependence. ZUBSOLV should be used as part of a complete treatment plan that includes counseling and psychosocial support.”
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Zubsolv, tablet, orally disintegrating
Indications and Usage, quoted from the label by Edenbridge Pharmaceuticals LLC. (NDA204242). Cross-references to other label sections are left out.
ZUBSOLV is indicated for treatment of opioid dependence. ZUBSOLV should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Source: DailyMed label, set id 57583c1d-9c44-4503-917d-68dba7377bd1, version 1, effective June 12, 2026. NDC 82111-201, one of 12 listings for this product.
Questions
What is Zubsolv used for?
The FDA label says: “ZUBSOLV is indicated for treatment of opioid dependence. ZUBSOLV should be used as part of a complete treatment plan that includes counseling and psychosocial support.”
What drug class is Zubsolv?
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 Zubsolv
- Is Zubsolv a controlled substance?Schedule III
- Generic for ZubsolvFDA Orange Book
- What is Buprenorphine and Naloxone used for?FDA label uses
- Is Buprenorphine and Naloxone a controlled substance?Schedule III
- Generic for SuboxoneFDA Orange Book
- Opioid Antagonists listFDA drug class
- Partial Opioid Agonists listFDA drug class
- Zubsolv Medicare Part D coverageBy plan and state
- NDC 54123-114Zubsolv NDC record
- NDC 54123-907Zubsolv NDC record
- NDC 54123-914Zubsolv NDC record
- Schedule III drugs listDEA schedule