Drug
Who makes phenytoin sodium?
22 companies list phenytoin sodium as a human prescription drug, including under the names Phenytek. Forms: capsule; capsule, extended release; injection. Routes: intramuscular, intravenous, 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 phenytoin sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDAANDA084307 | 4 | 4 |
| Sun Pharmaceutical Industries LimitedIndia | capsule, extended release | ANDAANDA040684, ANDA040731 | 3 | 13 |
| RemedyRepack, IncUnited States | capsule; capsule, extended release | ANDAANDA040684, ANDA204309 | 3 | 1 |
| International Medication Systems, Ltd.United States | capsule, extended release | ANDAANDA040684 | 2 | 3 |
| Bryant Ranch PrepackUnited States | capsule; capsule, extended release | ANDAANDA040684, ANDA204309 | 2 | 1 |
| HF Acquisition Co LLCUnited States | injection | ANDAANDA084307 | 2 | 1 |
| Henry Schein, Inc.United States | injection | ANDAANDA084307 | 2 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | capsule, extended release | ANDAANDA040684 | 2 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | capsule | ANDAANDA204309 | 1 | 5 |
| Unichem Laboratories Limited, IndiaIndia | capsule, extended release | ANDAANDA213834 | 1 | 5 |
| ProPharma Distribution, LLC.United States | injection | ANDAANDA084307 | 1 | 3 |
| Acella Pharmaceuticals, LLCUnited States | injection | ANDAANDA040573 | 1 | 1 |
| Amneal Ireland LimitedIreland | capsule | ANDAANDA040765 | 1 | 1 |
| Coupler LLCUnited States | capsule, extended release | ANDAANDA040684 | 1 | 1 |
| Direct RxUnited States | capsule | ANDAANDA040765 | 1 | 1 |
| Golden State Medical Supply Inc.United States | capsule, extended release | ANDAANDA040684 | 1 | 1 |
| Medical Purchasing Solutions, LLCUnited States | injection | ANDAANDA084307 | 1 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | capsule | ANDAANDA204309 | 1 | 1 |
| Proficient Rx LPUnited States | capsule, extended release | ANDAANDA040684 | 1 | 1 |
| AvPAK | capsule, extended release | ANDAANDA040684 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | capsule, extended release | ANDAANDA040684 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | capsule, extended release | ANDAANDA040298 | 1 | 0 |
Bulk ingredient listings
- B.V. KATWIJK CHEMIENetherlands · 1 NDC
- HARMAN FINOCHEM LIMITEDIndia · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Pharmacia and Upjohn Company LLC · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Swati Spentose Pvt. Ltd.India · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
Enquiry
Common questions
- Who makes phenytoin sodium?
- 22 companies list phenytoin sodium as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., Sun Pharmaceutical Industries Limited, RemedyRepack, Inc, International Medication Systems, Ltd., Bryant Ranch Prepack. 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 phenytoin sodium?
- 22 companies list 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.
- Who supplies phenytoin sodium active ingredient?
- 8 companies list phenytoin sodium as a bulk ingredient, including B.V. KATWIJK CHEMIE, HARMAN FINOCHEM LIMITED, MEDISCA Inc., Pharmacia and Upjohn Company LLC.