Phenytoin Sodium
Approved
Approval ID
cc521263-7ddc-4a79-a3ca-466848e32c23
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 12, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
phenytoin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0652
Application NumberANDA040298
Product Classification
M
Marketing Category
C73584
G
Generic Name
phenytoin sodium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (19)
PHENYTOIN SODIUMActive
Quantity: 100 mg in 1 1
Code: 4182431BJH
Classification: ACTIB
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT