Data / Drug companies / Fosphenytoin sodium
Fosphenytoin sodium: 8 companies and 16 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Fosphenytoin sodium is listed in the FDA National Drug Code Directory by 8 companies, with 16 products in commercial distribution. 13 of the products (81.2%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; injection, and the newest product started marketing on May 28, 2025.
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- Companies listing it
- 8
- Products
- 16
- Generic (ANDA) products
- 13 (81.2%)
- Application numbers
- 6
- Routes
- Intramuscular, Intravenous
- Brand names
- Cerebyx, Fosphenytoin
- openFDA record search
- api.fda.gov
Companies that list fosphenytoin sodium
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA | 3 | injection, solution | Generic drugs (ANDA) | May 28, 2025 |
| Pfizer Laboratories Div Pfizer Inc | 3 | injection, solution | New drug applications (NDA) | October 28, 2013 |
| Amneal Pharmaceuticals LLC | 2 | injection | Generic drugs (ANDA) | May 17, 2013 |
| Gland Pharma Limited | 2 | injection, solution | Generic drugs (ANDA) | October 13, 2023 |
| Hikma Pharmaceuticals USA Inc. | 2 | injection | Generic drugs (ANDA) | August 6, 2007 |
| Hikma Pharmaceuticals USA Inc. | 2 | injection, solution | Generic drugs (ANDA) | December 2, 2009 |
| Fresenius Kabi USA, LLC | 1 | injection, solution | Generic drugs (ANDA) | December 14, 2009 |
| Sagent Pharmaceuticals | 1 | injection, solution | Generic drugs (ANDA) | January 15, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 12 | 75% |
| Injection | 4 | 25% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 13 | 81.2% |
| New drug applications (NDA) | 3 | 18.8% |
Pharmacologic classes
| Class | Products |
|---|---|
| Anti-epileptic Agent | 16 |
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.