TOPIRAMATE
TOPIRAMATE
Approved
Approval ID
b8b097e0-bfa3-4bc3-ba1f-a62a0330f689
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2020
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 1
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 Code61919-817
Application NumberANDA090278
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOPIRAMATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2020
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TOPIRAMATEActive
Quantity: 100 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT