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Active ingredient

Phenytoin

54 finished FDA listings contain Phenytoin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PHENYTOIN, PHENYTOIN SODIUM
Dosage forms
Capsule, Capsule, Extended Release, Injection, Suspension, Tablet, Chewable
Routes
Intramuscular, Intravenous, Oral
Manufacturers / labelers
29
Strengths listed
100 mg/1 · 125 mg/5ml · 200 mg/1 · 30 mg/1 · 300 mg/1 · 50 mg/1 · 50 mg/ml
Brand names in FDA listings
Dilantin, Dilantin Infatabs, Dilantin-125, Extended Phenytoin Sodium, Phenytek, Phenytoin Infatabs

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 8183

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 008762VIATRIS1953-01-062
ANDA 084307HIKMA1975-07-1610
ANDA 084349VIATRIS1976-08-273
ANDA 084427PHARMACIA1979-02-263
ANDA 040298MYLAN1998-12-283
ANDA 040521TARO2004-03-084
ANDA 040684TARO2006-09-0512
ANDA 040573ACELLA2006-09-131
ANDA 040731SUN PHARM INDS2008-06-302
ANDA 040765AMNEAL PHARMS NY2008-11-122
ANDA 200691RISING2012-12-261
ANDA 200565TARO2014-04-175
ANDA 204309AUROBINDO PHARMA2015-06-105
ANDA 213834UNICHEM2022-10-131

Official labeling on DailyMed

Showing the 12 most recent of 49 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.