SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lamotrigine Tablets (Chewable, Dispersible), 5 mg

NDC 65841-689-01 in bottle of 100 tablets

100 tablets

Rx only

Lamotrigine Tablets (Chewable, Dispersible), 5 mg

Lamotrigine Tablets (Chewable, Dispersible), 25 mg

NDC 65841-690-01 in bottle of 100 tablets

100 tablets

Rx only

Lamotrigine Tablets (Chewable, Dispersible), 25 mg

Lamotrigine Tablets USP, 25 mg

NDC 65841-682-01 in bottle of 100 tablets

100 tablets

Rx only

Lamotrigine Tablets USP, 25 mg

Lamotrigine Tablets USP, 50 mg

NDC 65841-683-01 in bottle of 100 tablets

100 tablets

Rx only

Lamotrigine Tablets USP, 50 mg

Lamotrigine Tablets USP, 100 mg

NDC 65841-684-01 in bottle of 100 tablets

100 tablets

Rx only

Lamotrigine Tablets USP, 100 mg

Lamotrigine Tablets USP, 150 mg

NDC 65841-685-14 in bottle of 60 tablets

60 tablets

Rx only

Lamotrigine Tablets USP, 150 mg

Lamotrigine Tablets USP, 200 mg

NDC 65841-686-14 in bottle of 60 tablets

60 tablets

Rx only

Lamotrigine Tablets USP, 200 mg

Lamotrigine Tablets USP, 250 mg

NDC 65841-687-05 in bottle of 500 tablets

500 tablets

Rx only

Lamotrigine Tablets USP, 250 mg

LAMOTRIGINE
lamotrigine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-682
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	25 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE TO OFF- WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	ZC;79
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-682-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
2	NDC:65841-682-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
3	NDC:65841-682-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
4	NDC:65841-682-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
5	NDC:65841-682-11	25 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077633	01/27/2009

LAMOTRIGINE
lamotrigine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-683
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	50 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE TO OFF- WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	ZC;90
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-683-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
2	NDC:65841-683-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
3	NDC:65841-683-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
4	NDC:65841-683-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077633	01/27/2009

LAMOTRIGINE
lamotrigine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-684
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	100 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE TO OFF- WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	ZC;80
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-684-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
2	NDC:65841-684-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
3	NDC:65841-684-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
4	NDC:65841-684-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077633	01/27/2009

LAMOTRIGINE
lamotrigine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-685
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	150 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE TO OFF- WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	11mm
Flavor		Imprint Code	ZC;81
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-685-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
2	NDC:65841-685-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
3	NDC:65841-685-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077633	01/27/2009

LAMOTRIGINE
lamotrigine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-686
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	200 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE TO OFF- WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	13mm
Flavor		Imprint Code	ZC;82
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-686-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
2	NDC:65841-686-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
3	NDC:65841-686-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077633	01/27/2009

LAMOTRIGINE
lamotrigine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-687
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	250 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE TO OFF- WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	13mm
Flavor		Imprint Code	ZC;91
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-687-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
2	NDC:65841-687-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009
3	NDC:65841-687-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077633	01/27/2009

LAMOTRIGINE
lamotrigine tablet, chewable

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-689
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	5 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
BLACK CURRANT (UNII: 9755T40D11)

Product Characteristics
Color	WHITE (WHITE TO OFF- WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	10mm
Flavor	BERRY (Black Current)	Imprint Code	Z;13
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-689-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/23/2009
2	NDC:65841-689-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/23/2009
3	NDC:65841-689-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/23/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078009	01/23/2009

LAMOTRIGINE
lamotrigine tablet, chewable

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-690
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	25 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
BLACK CURRANT (UNII: 9755T40D11)

Product Characteristics
Color	WHITE (WHITE TO OFF- WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor	BERRY (Black Current)	Imprint Code	Z;12
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-690-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/23/2009
2	NDC:65841-690-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/23/2009
3	NDC:65841-690-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/23/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078009	01/23/2009

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(65841-682, 65841-683, 65841-684, 65841-685, 65841-686, 65841-687, 65841-689, 65841-690) , MANUFACTURE(65841-682, 65841-683, 65841-684, 65841-685, 65841-686, 65841-687, 65841-689, 65841-690)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		677605858	ANALYSIS(65841-682, 65841-683, 65841-684, 65841-685, 65841-686, 65841-687, 65841-689, 65841-690) , MANUFACTURE(65841-682, 65841-683, 65841-684, 65841-685, 65841-686, 65841-687, 65841-689, 65841-690)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-682, 65841-683, 65841-684, 65841-685, 65841-686, 65841-687, 65841-689, 65841-690) , MANUFACTURE(65841-682, 65841-683, 65841-684, 65841-685, 65841-686, 65841-687, 65841-689, 65841-690)

LAMOTRIGINE TABLETS and LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE).

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL