Drug
Who makes phenytoin?
12 companies list phenytoin as a human prescription drug, including under the names Dilantin-125, Dilantin Infatabs. Forms: suspension; tablet, chewable. 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 phenytoin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sun Pharmaceutical Industries LimitedIndia | suspension; tablet, chewable | ANDAANDA040521, ANDA200565 | 2 | 13 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | suspension; tablet, chewable | ANDAANDA040521, ANDA200565 | 2 | 5 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, chewable | ANDAANDA084427, ANDA200565 | 2 | 1 |
| Viatris Inc.India | suspension | NDANDA008762 | 1 | 18 |
| PAI Holdings, LLCUnited States | suspension | ANDAANDA040521 | 1 | 1 |
| RemedyRepack, IncUnited States | tablet, chewable | ANDAANDA200565 | 1 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet, chewable | ANDAANDA200691 | 1 | 1 |
| South Atlantic Corporation LLCUnited States | suspension | ANDAANDA040521 | 1 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet, chewable | ANDAANDA200565 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | suspension | NDA AUTHORIZED GENERICNDA008762 | 1 | 0 |
| Parke-Davis Div of Pfizer Inc | tablet, chewable | ANDAANDA084427 | 1 | 0 |
| Prasco Laboratories | tablet, chewable | ANDAANDA084427 | 1 | 0 |
Bulk ingredient listings
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- B.V. KATWIJK CHEMIENetherlands · 1 NDC
- HARMAN FINOCHEM LIMITEDIndia · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- Pharmacia and Upjohn Company LLC · 1 NDC
- Swati Spentose Pvt. Ltd.India · 1 NDC
Enquiry
Common questions
- Who makes phenytoin?
- 12 companies list phenytoin as a human prescription drug in the openFDA NDC Directory, led by Sun Pharmaceutical Industries Limited, Pharma Packaging Solutions, LLC dba Tjoapack, LLC, NCS HealthCare of KY, LLC dba Vangard Labs, Viatris Inc., PAI Holdings, LLC. 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 Dilantin-125?
- 10 companies list phenytoin 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 phenytoin active ingredient?
- 6 companies list phenytoin as a bulk ingredient, including Professional Compounding Centers of America dba PCCA, B.V. KATWIJK CHEMIE, HARMAN FINOCHEM LIMITED, LETCO MEDICAL, LLC.