Dilantin Infatabs
These highlights do not include all the information needed to use DILANTIN safely and effectively. See full prescribing information for DILANTIN. INFATABS DILANTIN (phenytoin chewable tablets), for oral useInitial U.S. Approval: 1953
Approved
Approval ID
ca119a89-2394-4d34-8078-cd1fa4e8e2f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2023
Manufacturers
FDA
Parke-Davis Div of Pfizer Inc
DUNS: 829076962
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 Code0071-0007
Application NumberANDA084427
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenytoin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2022
FDA Product Classification
INGREDIENTS (8)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PHENYTOINActive
Quantity: 50 mg in 1 1
Code: 6158TKW0C5
Classification: ACTIB
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT