Data / Drug companies / Primidone
Primidone: 23 companies and 44 products in the FDA NDC directory
Primidone is listed in the FDA National Drug Code Directory by 23 companies, with 44 products in commercial distribution. 42 of the products (95.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, and the newest product started marketing on May 1, 2025.
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- Companies listing it
- 23
- Products
- 44
- Generic (ANDA) products
- 42 (95.5%)
- Application numbers
- 8
- Routes
- Oral
- Brand names
- Mysoline
- openFDA record search
- api.fda.gov
Companies that list primidone
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| PD-Rx Pharmaceuticals, Inc. | 4 | tablet | Generic drugs (ANDA) | February 22, 2021 |
| Advagen Pharma Ltd | 3 | tablet | Generic drugs (ANDA) | June 28, 2022 |
| Aphena Pharma Solutions - Tennessee, LLC | 3 | tablet | Generic drugs (ANDA) | February 22, 2021 |
| American Health Packaging | 2 | tablet | Generic drugs (ANDA) | September 17, 2007 |
| Amneal Pharmaceuticals LLC | 2 | tablet | Generic drugs (ANDA) | December 24, 2009 |
| Amneal Pharmaceuticals of New York LLC | 2 | tablet | Generic drugs (ANDA) | December 24, 2009 |
| AvKARE | 2 | tablet | Generic drugs (ANDA) | March 22, 2022 |
| AvPAK | 2 | tablet | Generic drugs (ANDA) | May 19, 2011 |
| Bausch Health US, LLC | 2 | tablet | New drug applications (NDA) | June 24, 2009 |
| Carnegie Pharmaceuticals LLC | 2 | tablet | Generic drugs (ANDA) | May 1, 2024 |
| Dr. Reddy's Laboratories Limited | 2 | tablet | Generic drugs (ANDA) | October 3, 2008 |
| Golden State Medical Supply, Inc. | 2 | tablet | Generic drugs (ANDA) | May 24, 2001 |
| Lannett Company, Inc. | 2 | tablet | Generic drugs (ANDA) | May 24, 2001 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 2 | tablet | Generic drugs (ANDA) | February 22, 2021 |
| NorthStar RxLLC | 2 | tablet | Generic drugs (ANDA) | May 1, 2025 |
| Oxford Pharmaceuticals, LLC | 2 | tablet | Generic drugs (ANDA) | February 22, 2021 |
| Proficient Rx LP | 2 | tablet | Generic drugs (ANDA) | February 22, 2021 |
| Actavis Pharma, Inc. | 1 | tablet | Generic drugs (ANDA) | June 19, 2010 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | December 24, 2009 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | February 22, 2021 |
| Chartwell RX, LLC | 1 | tablet | Generic drugs (ANDA) | May 24, 2001 |
| Direct_Rx | 1 | tablet | Generic drugs (ANDA) | May 11, 2021 |
| TruPharma, LLC | 1 | tablet | Generic drugs (ANDA) | June 28, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 44 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 42 | 95.5% |
| New drug applications (NDA) | 2 | 4.5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Anti-epileptic Agent | 44 |
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.