Data / Drug companies / Phenytoin sodium
Phenytoin sodium: 24 companies and 34 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Phenytoin sodium is listed in the FDA National Drug Code Directory by 24 companies, with 34 products in commercial distribution. 34 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule, extended release; injection; capsule, and the newest product started marketing on May 13, 2026.
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- Companies listing it
- 24
- Products
- 34
- Generic (ANDA) products
- 34 (100.0%)
- Application numbers
- 8
- Routes
- Oral, Intramuscular, Intravenous
- Brand names
- Phenytek
- openFDA record search
- api.fda.gov
Companies that list phenytoin sodium
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 4 | injection | Generic drugs (ANDA) | July 16, 1975 |
| Remedyrepack Inc. | 3 | capsule, extended release; capsule | Generic drugs (ANDA) | September 3, 2019 |
| A-S Medication Solutions | 2 | capsule, extended release | Generic drugs (ANDA) | July 24, 2017 |
| Aphena Pharma Solutions - Tennessee, LLC | 2 | capsule, extended release | Generic drugs (ANDA) | September 5, 2006 |
| HF Acquisition Co LLC, DBA HealthFirst | 2 | injection | Generic drugs (ANDA) | September 19, 2018 |
| Henry Schein, Inc. | 2 | injection | Generic drugs (ANDA) | December 26, 2024 |
| Sun Pharmaceutical Industries, Inc. | 2 | capsule, extended release | Generic drugs (ANDA) | June 30, 2008 |
| Acella Pharmaceuticals, LLC | 1 | injection | Generic drugs (ANDA) | December 1, 2021 |
| American Health Packaging | 1 | capsule | Generic drugs (ANDA) | February 6, 2025 |
| Amneal Pharmaceuticals LLC | 1 | capsule | Generic drugs (ANDA) | December 16, 2009 |
| Aurobindo Pharma Limited | 1 | capsule | Generic drugs (ANDA) | June 10, 2015 |
| AvPAK | 1 | capsule, extended release | Generic drugs (ANDA) | March 3, 2026 |
| Bryant Ranch Prepack | 1 | capsule | Generic drugs (ANDA) | June 10, 2015 |
| Coupler LLC | 1 | capsule, extended release | Generic drugs (ANDA) | May 13, 2026 |
| Direct RX | 1 | capsule | Generic drugs (ANDA) | January 1, 2014 |
| Golden State Medical Supply, Inc. | 1 | capsule, extended release | Generic drugs (ANDA) | September 5, 2006 |
| Major Pharmaceuticals | 1 | capsule, extended release | Generic drugs (ANDA) | December 9, 2025 |
| Medical Purchasing Solutions, LLC | 1 | injection | Generic drugs (ANDA) | July 16, 1975 |
| Mylan Pharmaceuticals Inc. | 1 | capsule, extended release | Generic drugs (ANDA) | December 10, 2001 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 1 | capsule | Generic drugs (ANDA) | June 10, 2015 |
| ProPharma Distribution | 1 | injection | Generic drugs (ANDA) | July 16, 1975 |
| Proficient Rx LP | 1 | capsule, extended release | Generic drugs (ANDA) | September 5, 2006 |
| Sun Pharmaceutical Industries, Inc. | 1 | capsule, extended release | Generic drugs (ANDA) | September 5, 2006 |
| Unichem Pharmaceuticals (USA), Inc. | 1 | capsule, extended release | Generic drugs (ANDA) | November 12, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule, extended release | 16 | 47.1% |
| Injection | 11 | 32.4% |
| Capsule | 7 | 20.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 34 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Anti-epileptic Agent | 34 |
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.