Phenytoin
These highlights do not include all the information needed to use PHENYTOIN CHEWABLE TABLETS safely and effectively. See full prescribing information for PHENYTOIN CHEWABLE TABLETS. PHENYTOIN chewable tablets, for oral use Initial U.S. Approval: 1953
Approved
Approval ID
78b38e7b-1460-4adc-b738-320ffa6259c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2022
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc
DUNS: 145186370
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenytoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4146
Application NumberANDA200565
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenytoin
Product Specifications
Route of AdministrationORAL
Effective DateJune 28, 2022
FDA Product Classification
INGREDIENTS (10)
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
PhenytoinActive
Quantity: 50 mg in 1 1
Code: 6158TKW0C5
Classification: ACTIB
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT