Data / Drug companies / Naltrexone hydrochloride
Naltrexone hydrochloride: 24 companies and 45 products in the FDA NDC directory
Naltrexone hydrochloride is listed in the FDA National Drug Code Directory by 24 companies, with 45 products in commercial distribution. 45 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 coated, and the newest product started marketing on June 15, 2026.
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- Companies listing it
- 24
- Products
- 45
- Generic (ANDA) products
- 45 (100.0%)
- Application numbers
- 5
- Routes
- Oral
- openFDA record search
- api.fda.gov
Companies that list naltrexone hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 13 | tablet, film coated | Generic drugs (ANDA) | August 15, 2025 |
| Bryant Ranch Prepack | 4 | tablet, film coated | Generic drugs (ANDA) | August 15, 2025 |
| A-S Medication Solutions | 2 | tablet, film coated | Generic drugs (ANDA) | January 18, 2012 |
| Aphena Pharma Solutions - Tennessee, LLC | 2 | tablet, film coated | Generic drugs (ANDA) | March 22, 2002 |
| Aphena Pharma Solutions - Tennessee, LLC | 2 | tablet, film coated | Generic drugs (ANDA) | August 15, 2025 |
| Coupler LLC | 2 | tablet, film coated | Generic drugs (ANDA) | June 15, 2026 |
| Precision Dose, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | February 15, 2024 |
| Remedyrepack Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | May 20, 2025 |
| Accord Healthcare Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | January 18, 2012 |
| American Health Packaging | 1 | tablet, film coated | Generic drugs (ANDA) | June 3, 2013 |
| AvKARE | 1 | tablet, film coated | Generic drugs (ANDA) | March 26, 2015 |
| Bryant Ranch Prepack | 1 | tablet, film coated | Generic drugs (ANDA) | September 23, 2013 |
| Chartwell RX, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | July 21, 2017 |
| Elite Laboratories, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | August 15, 2025 |
| Golden State Medical Supply, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | March 22, 2002 |
| Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | October 6, 2023 |
| Major Pharmaceuticals | 1 | tablet, film coated | Generic drugs (ANDA) | February 29, 2012 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 1 | tablet, film coated | Generic drugs (ANDA) | February 29, 2012 |
| NuCare Pharmaceuticals,Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | February 15, 2024 |
| Proficient Rx LP | 1 | tablet, film coated | Generic drugs (ANDA) | February 29, 2012 |
| Redpharm Drug | 1 | tablet, film coated | Generic drugs (ANDA) | January 18, 2012 |
| SpecGx LLC | 1 | tablet, film coated | Generic drugs (ANDA) | March 22, 2002 |
| Sun Pharmaceutical Industries, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | February 29, 2012 |
| Tagi Pharma, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | September 23, 2013 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 45 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 45 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Opioid Antagonist | 45 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). 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.