Topiramate
Topiramate
Approved
Approval ID
47fd4c44-56fa-4864-af5d-7b65c7b746d7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2011
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
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 Code68387-558
Application NumberANDA079162
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2011
FDA Product Classification
INGREDIENTS (6)
TOPIRAMATEActive
Quantity: 25 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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 Code68387-559
Application NumberANDA079162
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2011
FDA Product Classification
INGREDIENTS (6)
TOPIRAMATEActive
Quantity: 100 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TOPIRAMATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68387-560
Application NumberANDA079162
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2011
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TOPIRAMATEActive
Quantity: 200 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB