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Lamotrigine Tablets

Dosage Form: tablet; chewable, dispersible tablet

Medically reviewed by Drugs.com. Last updated on Aug 1, 2020.

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 LABEL Item Code (Source) NDC:65841-682
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF- WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code ZC;79
Contains
Packaging
# Item Code Package Description
1 NDC:65841-682-11 25 TABLET in 1 BOTTLE
2 NDC:65841-682-16 90 TABLET in 1 BOTTLE
3 NDC:65841-682-01 100 TABLET in 1 BOTTLE
4 NDC:65841-682-05 500 TABLET in 1 BOTTLE
5 NDC:65841-682-10 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077633 01/27/2009
LAMOTRIGINE
lamotrigine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-683
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF- WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code ZC;90
Contains
Packaging
# Item Code Package Description
1 NDC:65841-683-16 90 TABLET in 1 BOTTLE
2 NDC:65841-683-01 100 TABLET in 1 BOTTLE
3 NDC:65841-683-05 500 TABLET in 1 BOTTLE
4 NDC:65841-683-10 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077633 01/27/2009
LAMOTRIGINE
lamotrigine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-684
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF- WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code ZC;80
Contains
Packaging
# Item Code Package Description
1 NDC:65841-684-16 90 TABLET in 1 BOTTLE
2 NDC:65841-684-01 100 TABLET in 1 BOTTLE
3 NDC:65841-684-05 500 TABLET in 1 BOTTLE
4 NDC:65841-684-10 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077633 01/27/2009
LAMOTRIGINE
lamotrigine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-685
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 150 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF- WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 11mm
Flavor Imprint Code ZC;81
Contains
Packaging
# Item Code Package Description
1 NDC:65841-685-14 60 TABLET in 1 BOTTLE
2 NDC:65841-685-16 90 TABLET in 1 BOTTLE
3 NDC:65841-685-05 500 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077633 01/27/2009
LAMOTRIGINE
lamotrigine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-686
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF- WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 13mm
Flavor Imprint Code ZC;82
Contains
Packaging
# Item Code Package Description
1 NDC:65841-686-14 60 TABLET in 1 BOTTLE
2 NDC:65841-686-16 90 TABLET in 1 BOTTLE
3 NDC:65841-686-05 500 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077633 01/27/2009
LAMOTRIGINE
lamotrigine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-687
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 250 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF- WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 13mm
Flavor Imprint Code ZC;91
Contains
Packaging
# Item Code Package Description
1 NDC:65841-687-14 60 TABLET in 1 BOTTLE
2 NDC:65841-687-16 90 TABLET in 1 BOTTLE
3 NDC:65841-687-05 500 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077633 01/27/2009
LAMOTRIGINE
lamotrigine tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-689
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 5 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MANNITOL
TRIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
BLACK CURRANT
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
Packaging
# Item Code Package Description
1 NDC:65841-689-16 90 TABLET, CHEWABLE in 1 BOTTLE
2 NDC:65841-689-01 100 TABLET, CHEWABLE in 1 BOTTLE
3 NDC:65841-689-05 500 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078009 01/23/2009
LAMOTRIGINE
lamotrigine tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65841-690
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 25 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MANNITOL
TRIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
BLACK CURRANT
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
Packaging
# Item Code Package Description
1 NDC:65841-690-16 90 TABLET, CHEWABLE in 1 BOTTLE
2 NDC:65841-690-01 100 TABLET, CHEWABLE in 1 BOTTLE
3 NDC:65841-690-05 500 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078009 01/23/2009
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare 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)
Cadila Healthcare Limited

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