TOPIRAMATE
Topiramate Tablets
Approved
Approval ID
999f8588-5708-4708-9ef2-5518b0884c10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2009
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TOPIRAMATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64725-0710
Application NumberANDA090278
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2009
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TOPIRAMATEActive
Quantity: 50 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TOPIRAMATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64725-0707
Application NumberANDA090278
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2009
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TOPIRAMATEActive
Quantity: 25 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT