topiramate

Basic Information

Product Name

topiramate

FDA Product Code

70518-1180

Regulatory Information

NDC Product Code

70518-1180

Application Number

ANDA078235

Marketing Category

C73584

Effective Date

February 14, 2024

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

TOPIRAMATE

Quantity: 50 mg in 1 1

Code: 0H73WJJ391

Class Code: ACTIB

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

Active Moieties

Code: 0H73WJJ391

topiramate

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYPROMELLOSES

MAGNESIUM STEARATE

SILICON DIOXIDE

SODIUM STARCH GLYCOLATE TYPE A POTATO

POLYETHYLENE GLYCOL, UNSPECIFIED

TALC

CELLULOSE, MICROCRYSTALLINE

TITANIUM DIOXIDE

ANHYDROUS LACTOSE

Active Moieties

TOPIRAMATE