Data / Drug companies / Buprenorphine hydrochloride
Buprenorphine hydrochloride: 10 companies and 21 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Buprenorphine hydrochloride is listed in the FDA National Drug Code Directory by 10 companies, with 21 products in commercial distribution. 14 of the products (66.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; film, soluble; injection, and the newest product started marketing on October 15, 2026.
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- Companies listing it
- 10
- Products
- 21
- Generic (ANDA) products
- 14 (66.7%)
- Application numbers
- 8
- Controlled substance schedule
- Schedule III
- Routes
- Sublingual, Buccal, Intramuscular, Intravenous
- Brand names
- Belbuca
- openFDA record search
- api.fda.gov
Companies that list buprenorphine hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| BioDelivery Sciences International Inc | 7 | film, soluble | New drug applications (NDA) | October 1, 2017 |
| Advagen Pharma Ltd | 4 | tablet | Generic drugs (ANDA) | February 1, 2026 |
| Pai Holdings, LLC DBA Pai Pharma | 2 | tablet | Generic drugs (ANDA) | October 12, 2023 |
| Remedyrepack Inc. | 2 | tablet | Generic drugs (ANDA) | February 10, 2026 |
| A-S Medication Solutions | 1 | tablet | Generic drugs (ANDA) | October 12, 2023 |
| Gland Pharma Limited | 1 | injection | Generic drugs (ANDA) | October 15, 2026 |
| Hikma Pharmaceuticals USA Inc. | 1 | injection | Generic drugs (ANDA) | May 25, 2005 |
| Hospira, Inc. | 1 | injection, solution | Generic drugs (ANDA) | June 14, 2005 |
| Par Health USA, LLC | 1 | injection | Generic drugs (ANDA) | July 30, 2015 |
| Somerset Therapeutics, LLC | 1 | injection | Generic drugs (ANDA) | February 11, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 9 | 42.9% |
| Film, soluble | 7 | 33.3% |
| Injection | 4 | 19% |
| Injection, solution | 1 | 4.8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 14 | 66.7% |
| New drug applications (NDA) | 7 | 33.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Partial Opioid Agonist | 21 |
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.