Label: LAMOTRIGINE tablet
LAMOTRIGINE tablet, chewable
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NDC Code(s):
65841-682-01,
65841-682-05,
65841-682-10,
65841-682-11, view more65841-682-16, 65841-683-01, 65841-683-05, 65841-683-10, 65841-683-16, 65841-684-01, 65841-684-05, 65841-684-10, 65841-684-16, 65841-685-05, 65841-685-14, 65841-685-16, 65841-686-05, 65841-686-14, 65841-686-16, 65841-687-05, 65841-687-14, 65841-687-16, 65841-689-01, 65841-689-05, 65841-689-16, 65841-690-01, 65841-690-05, 65841-690-16
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 26, 2023
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
LAMOTRIGINE
lamotrigine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-682 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE 25 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-682-11 25 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2009 2 NDC:65841-682-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2009 3 NDC:65841-682-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2009 4 NDC:65841-682-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2009 5 NDC:65841-682-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/27/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077633 01/27/2009 LAMOTRIGINE
lamotrigine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-683 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE 50 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077633 01/27/2009 LAMOTRIGINE
lamotrigine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-684 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE 100 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077633 01/27/2009 LAMOTRIGINE
lamotrigine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-685 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE 150 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077633 01/27/2009 LAMOTRIGINE
lamotrigine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-686 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE 200 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077633 01/27/2009 LAMOTRIGINE
lamotrigine tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-687 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE 250 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077633 01/27/2009 LAMOTRIGINE
lamotrigine tablet, chewableProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-689 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE 5 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078009 01/23/2009 LAMOTRIGINE
lamotrigine tablet, chewableProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-690 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE 25 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078009 01/23/2009 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations 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)