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Data / Drug companies / Phenytoin sodium

Phenytoin sodium: 24 companies and 34 products in the FDA NDC directory

Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).

Phenytoin sodium is listed in the FDA National Drug Code Directory by 24 companies, with 34 products in commercial distribution. 34 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule, extended release; injection; capsule, and the newest product started marketing on May 13, 2026.

The request: Get every company that lists phenytoin sodium in the FDA NDC directory, with headquarters, website and number of employees. $10 of work on sign-up, no card.

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Companies listing it
24
Products
34
Generic (ANDA) products
34 (100.0%)
Application numbers
8
Routes
Oral, Intramuscular, Intravenous
Brand names
Phenytek
openFDA record search
api.fda.gov

Companies that list phenytoin sodium

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Hikma Pharmaceuticals USA Inc.4injectionGeneric drugs (ANDA)July 16, 1975
Remedyrepack Inc.3capsule, extended release; capsuleGeneric drugs (ANDA)September 3, 2019
A-S Medication Solutions2capsule, extended releaseGeneric drugs (ANDA)July 24, 2017
Aphena Pharma Solutions - Tennessee, LLC2capsule, extended releaseGeneric drugs (ANDA)September 5, 2006
HF Acquisition Co LLC, DBA HealthFirst2injectionGeneric drugs (ANDA)September 19, 2018
Henry Schein, Inc.2injectionGeneric drugs (ANDA)December 26, 2024
Sun Pharmaceutical Industries, Inc.2capsule, extended releaseGeneric drugs (ANDA)June 30, 2008
Acella Pharmaceuticals, LLC1injectionGeneric drugs (ANDA)December 1, 2021
American Health Packaging1capsuleGeneric drugs (ANDA)February 6, 2025
Amneal Pharmaceuticals LLC1capsuleGeneric drugs (ANDA)December 16, 2009
Aurobindo Pharma Limited1capsuleGeneric drugs (ANDA)June 10, 2015
AvPAK1capsule, extended releaseGeneric drugs (ANDA)March 3, 2026
Bryant Ranch Prepack1capsuleGeneric drugs (ANDA)June 10, 2015
Coupler LLC1capsule, extended releaseGeneric drugs (ANDA)May 13, 2026
Direct RX1capsuleGeneric drugs (ANDA)January 1, 2014
Golden State Medical Supply, Inc.1capsule, extended releaseGeneric drugs (ANDA)September 5, 2006
Major Pharmaceuticals1capsule, extended releaseGeneric drugs (ANDA)December 9, 2025
Medical Purchasing Solutions, LLC1injectionGeneric drugs (ANDA)July 16, 1975
Mylan Pharmaceuticals Inc.1capsule, extended releaseGeneric drugs (ANDA)December 10, 2001
NCS HealthCare of Ky, LLC DBA Vangard Labs1capsuleGeneric drugs (ANDA)June 10, 2015
ProPharma Distribution1injectionGeneric drugs (ANDA)July 16, 1975
Proficient Rx LP1capsule, extended releaseGeneric drugs (ANDA)September 5, 2006
Sun Pharmaceutical Industries, Inc.1capsule, extended releaseGeneric drugs (ANDA)September 5, 2006
Unichem Pharmaceuticals (USA), Inc.1capsule, extended releaseGeneric drugs (ANDA)November 12, 2022

Dosage forms

Dosage formProductsShare
Capsule, extended release1647.1%
Injection1132.4%
Capsule720.6%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)34100%

Pharmacologic classes

ClassProducts
Anti-epileptic Agent34

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.