SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-647-14 in bottle of 60 tablets

Topiramate Tablets USP, 25 mg

60 tablets

Rx only

NDC 65841-648-14 in bottle of 60 tablets

Topiramate Tablets USP, 50 mg

60 tablets

Rx only

NDC 65841-649-14 in bottle of 60 tablets

Topiramate Tablets USP, 100 mg

60 tablets

Rx only

NDC 65841-650-14 in bottle of 60 tablets

Topiramate Tablets USP, 200 mg

60 tablets

Rx only

TOPIRAMATE
topiramate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-647
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	25 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	ZD;16
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-647-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
2	NDC:65841-647-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
3	NDC:65841-647-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
4	NDC:65841-647-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078235	03/27/2009

TOPIRAMATE
topiramate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-648
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	50 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZD;15
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-648-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
2	NDC:65841-648-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
3	NDC:65841-648-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
4	NDC:65841-648-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078235	03/27/2009

TOPIRAMATE
topiramate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-649
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	100 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	ZD;14
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-649-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
2	NDC:65841-649-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
3	NDC:65841-649-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
4	NDC:65841-649-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078235	03/27/2009

TOPIRAMATE
topiramate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-650
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)	TOPIRAMATE	200 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	ZD;13
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-650-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
2	NDC:65841-650-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
3	NDC:65841-650-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009
4	NDC:65841-650-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078235	03/27/2009

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-647, 65841-648, 65841-649, 65841-650) , MANUFACTURE(65841-647, 65841-648, 65841-649, 65841-650)

TOPIRAMATE TABLETS and TOPIRAMATE CAPSULES

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL