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Active ingredient

Fosphenytoin

16 finished FDA listings contain Fosphenytoin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
FOSPHENYTOIN SODIUM
Dosage forms
Injection, Injection, Solution
Routes
Intramuscular, Intravenous
Manufacturers / labelers
8
Strengths listed
50 mg/ml
Brand names in FDA listings
Cerebyx, Fosphenytoin

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 72236

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 020450PARKE DAVIS1996-08-053
ANDA 077989HIKMA2007-08-062
ANDA 078052FRESENIUS KABI USA2007-08-061
ANDA 078476AMNEAL2008-03-182
ANDA 078765HIKMA FARMACEUTICA2009-12-022
ANDA 214926GLAND2023-10-136

Official labeling on DailyMed

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