Topiramate

Basic Information

Product Name

Topiramate

FDA Product Code

43063-612

Regulatory Information

NDC Product Code

43063-612

Application Number

ANDA077627

Marketing Category

C73584

Effective Date

June 29, 2023

Territorial Authority

USA

FDA Title

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, for oral use Initial U.S. Approval: 1996

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TOPIRAMATE

Quantity: 50 mg in 1 1

Code: 0H73WJJ391

Class Code: ACTIB

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

Active Moieties

Code: 0H73WJJ391

Topiramate

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

MICROCRYSTALLINE CELLULOSE

HYPROMELLOSE, UNSPECIFIED

TITANIUM DIOXIDE

POLYSORBATE 80

POLYETHYLENE GLYCOL, UNSPECIFIED

FERRIC OXIDE YELLOW

STARCH, CORN

SODIUM STARCH GLYCOLATE TYPE A POTATO

FD&C YELLOW NO. 6

Active Moieties

TOPIRAMATE