NDC Code(s) : 29300-111-01, 29300-111-05, 29300-111-10, 29300-112-01, 29300-112-05, 29300-112-10, 29300-113-16, 29300-113-05, 29300-113-10, 29300-114-16, 29300-114-05, 29300-114-10
Packager : Unichem Pharmaceuticals (USA), Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lamotrigine Lamotrigine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-111
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE(UNII: U3H27498KS)
(LAMOTRIGINE - UNII:U3H27498KS) 		LAMOTRIGINE25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (Caplet) Size 8 mm
Flavor Imprint Code U;U;111
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29300-111-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
2NDC:29300-111-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
3NDC:29300-111-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090170 11/01/2011
Lamotrigine Lamotrigine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-112
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE(UNII: U3H27498KS)
(LAMOTRIGINE - UNII:U3H27498KS) 		LAMOTRIGINE100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color WHITE Score 2 pieces
Shape TRIANGLE (Trigonal) Size 11 mm
Flavor Imprint Code U;U;112
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29300-112-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
2NDC:29300-112-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
3NDC:29300-112-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090170 11/01/2011
Lamotrigine Lamotrigine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-113
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE(UNII: U3H27498KS)
(LAMOTRIGINE - UNII:U3H27498KS) 		LAMOTRIGINE150 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color WHITE Score 2 pieces
Shape TRIANGLE (Trigonal) Size 12 mm
Flavor Imprint Code U;U;113
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29300-113-1660 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
2NDC:29300-113-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
3NDC:29300-113-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090170 11/01/2011
Lamotrigine Lamotrigine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-114
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE(UNII: U3H27498KS)
(LAMOTRIGINE - UNII:U3H27498KS) 		LAMOTRIGINE200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color BLUE (Light Blue) Score 2 pieces
Shape TRIANGLE (Trigonal) Size 12 mm
Flavor Imprint Code U;U;114
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29300-114-1660 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
2NDC:29300-114-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
3NDC:29300-114-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090170 11/01/2011

LABELER - Unichem Pharmaceuticals (USA), Inc.(181620514)

PRINCIPAL DISPLAY PANEL

100T label-25 mg100T label-25 mg100T label-25 mg100T label-25 mg