TOPIRAMATE
These highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets, USP Rx Only Initial U.S. Approval - 1996
Approved
Approval ID
efd1106b-d369-4651-b703-b0985ce93b79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2011
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 Code16590-824
Application NumberANDA079153
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2011
FDA Product Classification
INGREDIENTS (10)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TOPIRAMATEActive
Quantity: 25 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TOPIRAMATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-825
Application NumberANDA079153
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2011
FDA Product Classification
INGREDIENTS (11)
TOPIRAMATEActive
Quantity: 50 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TOPIRAMATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-817
Application NumberANDA079153
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2011
FDA Product Classification
INGREDIENTS (11)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TOPIRAMATEActive
Quantity: 100 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT