Data / Drug companies / Buprenorphine hydrochloride and naloxone hydrochloride
Buprenorphine hydrochloride and naloxone hydrochloride: 3 companies and 14 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Buprenorphine hydrochloride and naloxone hydrochloride is listed in the FDA National Drug Code Directory by 3 companies, with 14 products in commercial distribution. 2 of the products (14.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, orally disintegrating; tablet, and the newest product started marketing on June 12, 2026.
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- Companies listing it
- 3
- Products
- 14
- Generic (ANDA) products
- 2 (14.3%)
- Application numbers
- 2
- Controlled substance schedule
- Schedule III
- Routes
- Sublingual
- Brand names
- Zubsolv, Buprenorphine and Naloxone
- openFDA record search
- api.fda.gov
Companies that list buprenorphine hydrochloride and naloxone hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Edenbridge Pharmaceuticals LLC. | 6 | tablet, orally disintegrating | New drug applications (NDA) | June 12, 2026 |
| Orexo US, Inc. | 6 | tablet, orally disintegrating | New drug applications (NDA) | December 11, 2014 |
| Pai Holdings, LLC DBA Pai Pharma | 2 | tablet | Generic drugs (ANDA) | September 5, 2023 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, orally disintegrating | 12 | 85.7% |
| Tablet | 2 | 14.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 12 | 85.7% |
| Generic drugs (ANDA) | 2 | 14.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Opioid Antagonist | 14 |
| Partial Opioid Agonist | 14 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.