TOPIRAMATE
Topiramate Tablets
Approved
Approval ID
50bc013e-b5df-40e0-95e5-2527a62dcda0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 3
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 Code42549-621
Application NumberANDA090278
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2012
FDA Product Classification
INGREDIENTS (12)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TOPIRAMATEActive
Quantity: 100 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TOPIRAMATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-620
Application NumberANDA090278
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2012
FDA Product Classification
INGREDIENTS (11)
TOPIRAMATEActive
Quantity: 50 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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 GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TOPIRAMATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-619
Application NumberANDA090278
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2012
FDA Product Classification
INGREDIENTS (10)
TOPIRAMATEActive
Quantity: 25 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT