Topiramate
These highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP for oral useInitial U.S. Approval: 1996
Approved
Approval ID
17471bd6-4f48-40e0-952e-6a69bd0eeec9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2017
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-9950
Application NumberANDA079162
Product Classification
M
Marketing Category
C73584
G
Generic Name
Topiramate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 17, 2015
FDA Product Classification
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TOPIRAMATEActive
Quantity: 50 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT