Data / Drug companies / Phenytoin
Phenytoin: 12 companies and 15 products in the FDA NDC directory
Phenytoin is listed in the FDA National Drug Code Directory by 12 companies, with 15 products in commercial distribution. 13 of the products (86.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, chewable; suspension, and the newest product started marketing on May 3, 2024.
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- Companies listing it
- 12
- Products
- 15
- Generic (ANDA) products
- 13 (86.7%)
- Application numbers
- 5
- Routes
- Oral
- Brand names
- Dilantin-125, Dilantin Infatabs
- openFDA record search
- api.fda.gov
Companies that list phenytoin
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| American Health Packaging | 2 | tablet, chewable; suspension | Generic drugs (ANDA) | January 10, 2019 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 2 | tablet, chewable | Generic drugs (ANDA) | November 23, 2021 |
| Sun Pharmaceutical Industries, Inc. | 2 | tablet, chewable; suspension | Generic drugs (ANDA) | April 17, 2014 |
| Atlantic Biologicals Corp. | 1 | suspension | Generic drugs (ANDA) | April 8, 2004 |
| Major Pharmaceuticals | 1 | tablet, chewable | Generic drugs (ANDA) | April 17, 2014 |
| Mylan Pharmaceuticals Inc. | 1 | suspension | Authorized generics (NDA) | April 22, 2020 |
| Pai Holdings, LLC DBA Pai Pharma | 1 | suspension | Generic drugs (ANDA) | April 8, 2004 |
| Parke-Davis Div of Pfizer Inc | 1 | tablet, chewable | Generic drugs (ANDA) | February 26, 1979 |
| Prasco Laboratories | 1 | tablet, chewable | Generic drugs (ANDA) | November 23, 2021 |
| Remedyrepack Inc. | 1 | tablet, chewable | Generic drugs (ANDA) | November 10, 2017 |
| Rising Pharma Holdings, Inc. | 1 | tablet, chewable | Generic drugs (ANDA) | May 3, 2024 |
| Viatris Specialty LLC | 1 | suspension | New drug applications (NDA) | April 19, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, chewable | 9 | 60% |
| Suspension | 6 | 40% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 13 | 86.7% |
| New drug applications (NDA) | 1 | 6.7% |
| Authorized generics (NDA) | 1 | 6.7% |
Pharmacologic classes
| Class | Products |
|---|---|
| Anti-epileptic Agent | 15 |
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.