Drug
Who makes extended phenytoin sodium?
4 companies list extended phenytoin sodium as a human prescription drug, including under the names DILANTIN, Phenytek. Forms: capsule, extended release. Routes: oral.
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 extended phenytoin sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Viatris Inc.India | capsule, extended release | ANDAANDA084349 | 2 | 18 |
| Coupler LLCUnited States | capsule, extended release | ANDAANDA040298 | 1 | 1 |
| RemedyRepack, IncUnited States | capsule, extended release | ANDAANDA084349 | 1 | 1 |
| Mylan Pharmaceuticals, Inc. | capsule, extended release | ANDAANDA040298 | 1 | 0 |
Enquiry
Common questions
- Who makes extended phenytoin sodium?
- 4 companies list extended phenytoin sodium as a human prescription drug in the openFDA NDC Directory, led by Viatris Inc., Coupler LLC, RemedyRepack, Inc, Mylan Pharmaceuticals, Inc.. 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 extended phenytoin sodium?
- 4 companies list extended phenytoin sodium under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.