Data / Drug companies / Buprenorphine and naloxone
Buprenorphine and naloxone: 22 companies and 65 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Buprenorphine and naloxone is listed in the FDA National Drug Code Directory by 22 companies, with 65 products in commercial distribution. 65 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; film; film, soluble, and the newest product started marketing on July 3, 2026.
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- Companies listing it
- 22
- Products
- 65
- Generic (ANDA) products
- 65 (100.0%)
- Application numbers
- 15
- Controlled substance schedule
- Schedule III
- Routes
- Sublingual, Buccal
- Brand names
- Buprenorphine HCl and Naloxone HCl
- openFDA record search
- api.fda.gov
Companies that list buprenorphine and naloxone
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Camber Pharmaceuticals, Inc. | 6 | film, soluble; tablet | Generic drugs (ANDA) | May 1, 2026 |
| Redpharm Drug | 6 | film; tablet | Generic drugs (ANDA) | August 29, 2023 |
| Bryant Ranch Prepack | 5 | tablet | Generic drugs (ANDA) | April 13, 2020 |
| Alvogen Inc. | 4 | film | Generic drugs (ANDA) | February 11, 2019 |
| Aveva Drug Delivery Systems Inc. | 4 | film | Generic drugs (ANDA) | March 7, 2025 |
| Bryant Ranch Prepack | 4 | tablet | Generic drugs (ANDA) | April 13, 2020 |
| Dr. Reddy's Laboratories Inc. | 4 | film, soluble | Generic drugs (ANDA) | June 14, 2018 |
| Ingenus Pharmaceuticals, LLC | 4 | film | Generic drugs (ANDA) | August 29, 2023 |
| Mylan Pharmaceuticals Inc. | 4 | film | Generic drugs (ANDA) | April 17, 2020 |
| Actavis Pharma, Inc. | 2 | tablet | Generic drugs (ANDA) | March 4, 2013 |
| American Health Packaging | 2 | tablet | Generic drugs (ANDA) | March 14, 2022 |
| Amneal Pharmaceuticals LLC | 2 | tablet | Generic drugs (ANDA) | February 22, 2013 |
| Ascend Laboratories, LLC | 2 | tablet | Generic drugs (ANDA) | July 3, 2026 |
| AvPAK | 2 | tablet | Generic drugs (ANDA) | December 8, 2016 |
| Bryant Ranch Prepack | 2 | tablet | Generic drugs (ANDA) | April 13, 2020 |
| Hikma Pharmaceuticals USA Inc. | 2 | tablet | Generic drugs (ANDA) | June 27, 2014 |
| Lannett Company, Inc. | 2 | tablet | Generic drugs (ANDA) | September 19, 2016 |
| Major Pharmaceuticals | 2 | tablet | Generic drugs (ANDA) | June 27, 2014 |
| Rhodes Pharmaceuticals LLC | 2 | tablet | Generic drugs (ANDA) | April 13, 2020 |
| Sun Pharmaceutical Industries, Inc. | 2 | tablet | Generic drugs (ANDA) | July 18, 2017 |
| Remedyrepack Inc. | 1 | tablet | Generic drugs (ANDA) | March 16, 2022 |
| Unit Dose Solutions, Inc. | 1 | tablet | Generic drugs (ANDA) | February 18, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 36 | 55.4% |
| Film | 21 | 32.3% |
| Film, soluble | 8 | 12.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 65 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Opioid Antagonist | 65 |
| Partial Opioid Agonist | 65 |
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.