Drug
Who makes fosphenytoin sodium?
8 companies list fosphenytoin sodium as a human prescription drug, including under the names CEREBYX. Forms: injection; injection, solution. Routes: intramuscular, intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing fosphenytoin sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USAIndia | injection, solution | ANDAANDA214926 | 3 | 9 |
| Pfizer Laboratories Div Pfizer Inc | injection, solution | NDANDA020450 | 3 | 0 |
| GLAND PHARMA LIMITEDIndia | injection, solution | ANDAANDA214926 | 2 | 4 |
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDAANDA077989 | 2 | 4 |
| Amneal Ireland LimitedIreland | injection | ANDAANDA078476 | 2 | 1 |
| West-Ward Pharmaceuticals Corp | injection, solution | ANDAANDA078765 | 2 | 0 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA078052 | 1 | 6 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA214926 | 1 | 0 |
Bulk ingredient listings
- Alchymars ICM SM Private LimitedIndia · 1 NDC
- Guangan Kingday Pharma & Chem Co., Ltd. · 1 NDC
- MAHI DRUGS PRIVATE LIMITEDIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
Orange Book patents
5 unexpired patents list fosphenytoin sodium as the active ingredient, expiring between Mar 2029 and Feb 2033. Application holder: LUPIN INC.
Enquiry
Common questions
- Who makes fosphenytoin sodium?
- 8 companies list fosphenytoin sodium as a human prescription drug in the openFDA NDC Directory, led by Glenmark Pharmaceuticals Inc., USA, Pfizer Laboratories Div Pfizer Inc, GLAND PHARMA LIMITED, Hikma Pharmaceuticals USA Inc., Amneal Ireland Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic CEREBYX?
- 7 companies list fosphenytoin sodium under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies fosphenytoin sodium active ingredient?
- 4 companies list fosphenytoin sodium as a bulk ingredient, including Alchymars ICM SM Private Limited, Guangan Kingday Pharma & Chem Co., Ltd., MAHI DRUGS PRIVATE LIMITED, Sun Pharmaceutical Industries Limited.