Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Taro Pharmaceutical Industries Ltd.
Taro Pharmaceuticals U.S.A., Inc
600072078
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenytoin
Product Details
NDC Product Code
51672-4146Application Number
ANDA200565Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 28, 2022Lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
PhenytoinActive
Code: 6158TKW0C5Class: ACTIBQuantity: 50 mg in 1 1
D&C Yellow No. 10Inactive
Code: 35SW5USQ3GClass: IACT
Saccharin sodiumInactive
Code: SB8ZUX40TYClass: IACT
aluminum oxideInactive
Code: LMI26O6933Class: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8Class: IACT
SucroseInactive
Code: C151H8M554Class: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT