Data / Drug companies / Baclofen
Baclofen: 65 companies and 234 products in the FDA NDC directory
Baclofen is listed in the FDA National Drug Code Directory by 65 companies, with 234 products in commercial distribution. 217 of the products (92.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; injection; solution, and the newest product started marketing on October 26, 2026.
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- Companies listing it
- 65
- Products
- 234
- Generic (ANDA) products
- 217 (92.7%)
- Application numbers
- 27
- Routes
- Oral, Intrathecal
- Brand names
- Lyvispah, Ozobax DS, Fleqsuvy
- openFDA record search
- api.fda.gov
Companies that list baclofen
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 21 | tablet | Generic drugs (ANDA) | June 15, 2024 |
| Advanced Rx of Tennessee, LLC | 13 | tablet | Generic drugs (ANDA) | December 10, 2025 |
| Bryant Ranch Prepack | 12 | tablet | Generic drugs (ANDA) | October 14, 2020 |
| Remedyrepack Inc. | 11 | tablet | Generic drugs (ANDA) | May 12, 2026 |
| Advagen Pharma Ltd | 9 | tablet; injection | Generic drugs (ANDA) | June 3, 2025 |
| Bryant Ranch Prepack | 9 | tablet | Generic drugs (ANDA) | June 15, 2024 |
| A-S Medication Solutions | 8 | tablet | Generic drugs (ANDA) | December 6, 2018 |
| Preferred Pharmaceuticals Inc. | 7 | tablet | Generic drugs (ANDA) | July 22, 2026 |
| Amneal Pharmaceuticals LLC | 6 | kit; injection | New drug applications (NDA) | June 12, 2022 |
| Aphena Pharma Solutions - Tennessee, LLC | 6 | tablet | Generic drugs (ANDA) | January 25, 2022 |
| Asclemed USA, Inc. | 6 | tablet | Generic drugs (ANDA) | February 5, 2024 |
| Method Pharmaceuticals, LLC | 6 | tablet | Generic drugs (ANDA) | June 1, 2025 |
| Major Pharmaceuticals | 5 | tablet | Generic drugs (ANDA) | November 1, 2025 |
| PD-Rx Pharmaceuticals, Inc. | 5 | tablet | Generic drugs (ANDA) | April 1, 2018 |
| TruPharma, LLC | 5 | tablet; solution | Generic drugs (ANDA) | February 5, 2024 |
| Cardinal Health 107, LLC | 4 | tablet | Generic drugs (ANDA) | March 23, 2026 |
| Maia Pharmaceuticals, Inc. | 4 | injection | Generic drugs (ANDA) | April 2, 2021 |
| NuCare Pharmaceuticals,Inc. | 4 | tablet | Generic drugs (ANDA) | March 1, 2024 |
| Proficient Rx LP | 4 | tablet | Generic drugs (ANDA) | December 1, 2005 |
| Sagent Pharmaceuticals | 4 | injection, solution | Generic drugs (ANDA) | July 15, 2021 |
| Zydus Lifesciences Limited | 4 | tablet | Generic drugs (ANDA) | June 20, 2024 |
| Zydus Pharmaceuticals USA Inc. | 4 | tablet | Generic drugs (ANDA) | June 20, 2024 |
| American Health Packaging | 3 | tablet | Generic drugs (ANDA) | May 26, 2024 |
| Amneal Pharmaceuticals LLC | 3 | granule | New drug applications (NDA) | June 1, 2023 |
| AvPAK | 3 | tablet | Generic drugs (ANDA) | May 11, 2021 |
| Chartwell RX, LLC | 3 | tablet | Generic drugs (ANDA) | September 22, 2021 |
| Eywa Pharma Inc | 3 | tablet | Generic drugs (ANDA) | May 27, 2021 |
| Golden State Medical Supply, Inc. | 3 | tablet | Generic drugs (ANDA) | January 25, 2022 |
| Lannett Company, Inc. | 3 | tablet | Generic drugs (ANDA) | September 22, 2021 |
| Lifestar Pharma LLC | 3 | tablet | Generic drugs (ANDA) | January 26, 2022 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 3 | tablet | Generic drugs (ANDA) | January 26, 2022 |
| Rising Pharma Holdings, Inc. | 3 | tablet | Generic drugs (ANDA) | March 1, 2024 |
| Unichem Pharmaceuticals (USA), Inc. | 3 | tablet | Generic drugs (ANDA) | June 15, 2023 |
| XLCare Pharmaceuticals, Inc. | 3 | tablet | Generic drugs (ANDA) | February 5, 2025 |
| Aurobindo Pharma Limited | 2 | tablet | Generic drugs (ANDA) | July 13, 2021 |
| Direct_Rx | 2 | tablet | Generic drugs (ANDA) | June 28, 2024 |
| Marlex Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | May 1, 2020 |
| Medcore LLC | 2 | tablet | Generic drugs (ANDA) | March 27, 2026 |
| NorthStar Rx LLC | 2 | tablet | Generic drugs (ANDA) | January 1, 2011 |
| PD-Rx Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | July 1, 2007 |
| Par Health USA, LLC | 2 | tablet | Generic drugs (ANDA) | August 30, 2005 |
| Proficient Rx LP | 2 | tablet | Generic drugs (ANDA) | April 1, 2018 |
| Redpharm Drug | 2 | tablet | Generic drugs (ANDA) | July 9, 2020 |
| Teva Pharmaceuticals USA, Inc. | 2 | tablet | Generic drugs (ANDA) | July 21, 1988 |
| Acella Pharmaceuticals, LLC | 1 | solution | New drug applications (NDA) | October 26, 2026 |
| Ani Pharmaceuticals, Inc. | 1 | suspension | Generic drugs (ANDA) | March 18, 2024 |
| Anvi Pharmaceuticals Inc | 1 | granule | New drug applications (NDA) | September 1, 2026 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | tablet | Generic drugs (ANDA) | August 30, 2005 |
| Atlantic Biologicals Corp. | 1 | solution | Authorized generics (NDA) | October 12, 2023 |
| Aurobindo Pharma Limited | 1 | tablet | Generic drugs (ANDA) | November 21, 2025 |
| Azurity Pharmaceuticals, Inc. | 1 | suspension | New drug applications (NDA) | February 7, 2022 |
| Coupler LLC | 1 | tablet | Generic drugs (ANDA) | April 23, 2026 |
| Hawaii Repack, Inc. | 1 | tablet | Generic drugs (ANDA) | July 13, 2021 |
| Nexus Pharmaceuticals LLC | 1 | injection | Generic drugs (ANDA) | February 22, 2023 |
| Northwind Health Company, LLC | 1 | tablet | Generic drugs (ANDA) | September 27, 2023 |
| PD-Rx Pharmaceuticals, Inc. | 1 | tablet | Generic drugs (ANDA) | July 21, 1988 |
| Palmetto Pharmaceuticals Inc. | 1 | solution | Authorized generics (NDA) | September 25, 2024 |
| Phoenix RX LLC | 1 | tablet | Generic drugs (ANDA) | July 9, 2020 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | January 1, 2011 |
| Quality Care Products, LLC | 1 | tablet | Generic drugs (ANDA) | May 21, 2024 |
| Rosemont Pharmaceuticals LLC | 1 | solution | New drug applications (NDA) | October 12, 2023 |
| Slayback Pharma LLC | 1 | suspension | Generic drugs (ANDA) | June 19, 2023 |
| Sola Pharmaceuticals, LLC | 1 | tablet | Generic drugs (ANDA) | March 21, 2025 |
| Trifluent Pharma, LLC | 1 | solution | Generic drugs (ANDA) | June 5, 2025 |
| Wilshire Pharmaceuticals, Inc. | 1 | suspension | Authorized generics (NDA) | April 1, 2023 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 200 | 85.5% |
| Injection | 9 | 3.8% |
| Solution | 8 | 3.4% |
| Kit | 5 | 2.1% |
| Injection, solution | 4 | 1.7% |
| Suspension | 4 | 1.7% |
| Granule | 4 | 1.7% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 217 | 92.7% |
| New drug applications (NDA) | 13 | 5.6% |
| Authorized generics (NDA) | 4 | 1.7% |
Pharmacologic classes
| Class | Products |
|---|---|
| gamma-Aminobutyric Acid-ergic Agonist | 229 |
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.