NDC Code(s) : 52125-061-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TopiramateTopiramate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-061(NDC:68462-108)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE(UNII: 0H73WJJ391)
(TOPIRAMATE - UNII:0H73WJJ391) 		TOPIRAMATE25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 1000000(UNII: HZ58M6D839)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER BUFFALO, COOKED(UNII: RM3G76I0A1)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color white Score no score
Shape ROUND (TABLET, FILM COATED) Size 6 mm
Flavor Imprint Code G;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-061-0230 in 1 BLISTER PACK Type 0: Not a Combination Product19/07/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077627 07/19/2012 10/31/2013

PRINCIPAL DISPLAY PANEL

DRUG: Topiramate

GENERIC: Topiramate

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 52125-061-02

STRENGTH:25 mg

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: 30

QTY: 30




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