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, USP] Initial U.S. Approval:[1996]
Approved
Approval ID
23d9e299-f9a3-4c91-91e0-0aaeeb6c3772
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2017
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code43353-696
Application NumberANDA079162
Product Classification
M
Marketing Category
C73584
G
Generic Name
topiramate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2010
FDA Product Classification
INGREDIENTS (9)
TOPIRAMATEActive
Quantity: 100 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Polyethylene Glycol 400Inactive
Code: B697894SGQ
Classification: IACT