Topiramate

Basic Information

Product Name

Topiramate

FDA Product Code

70518-2419

Regulatory Information

NDC Product Code

70518-2419

Application Number

ANDA076343

Marketing Category

C73584

Effective Date

February 29, 2024

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

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

HYPROMELLOSE 2910 (3 MPA.S)

Code: 0VUT3PMY82

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

TOPIRAMATE

Quantity: 50 mg in 1 1

Code: 0H73WJJ391

Class Code: ACTIB

Active Moieties

Code: 0H73WJJ391

Topiramate

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

SODIUM STARCH GLYCOLATE TYPE A POTATO

STARCH, CORN

CELLULOSE, MICROCRYSTALLINE

HYPROMELLOSE 2910 (3 MPA.S)

MAGNESIUM STEARATE

POLYETHYLENE GLYCOL 400

TITANIUM DIOXIDE

HYPROMELLOSE 2910 (6 MPA.S)

POLYSORBATE 80

FERRIC OXIDE YELLOW

FERRIC OXIDE RED

Active Moieties

TOPIRAMATE