Lamotrigine (Page 13 of 13)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 82009-131-10 in bottle of 1000 tablets

Lamotrigine Tablets USP, 25 mg

R_x only

1000 tablets

Lamotrigine Tablets USP, 25 mg

NDC 82009-132-10 in bottle of 1000 tablets

Lamotrigine Tablets USP, 100 mg

R_x only

1000 tablets

Lamotrigine Tablets USP, 100 mg

NDC 82009-133-05 in bottle of 500 tablets

Lamotrigine Tablets USP, 150 mg

R_x only

500 tablets

Lamotrigine Tablets USP, 150 mg

NDC 82009-134-05 in bottle of 500 tablets

Lamotrigine Tablets USP, 200 mg

R_x only

500 tablets

Lamotrigine Tablets USP, 200 mg

LAMOTRIGINE lamotrigine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-131 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 Multilevel Packaging 1 NDC:82009-131-10 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077633 08/03/2023

LAMOTRIGINE lamotrigine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-132 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 Multilevel Packaging 1 NDC:82009-132-10 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077633 08/03/2023

LAMOTRIGINE lamotrigine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-133 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 Multilevel Packaging 1 NDC:82009-133-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077633 08/03/2023

LAMOTRIGINE lamotrigine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82009-134 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 Multilevel Packaging 1 NDC:82009-134-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077633 08/03/2023

Labeler — Quallent Pharmaceuticals Health LLC (815564528)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		677605858	ANALYSIS (82009-131), ANALYSIS (82009-132), ANALYSIS (82009-133), ANALYSIS (82009-134), MANUFACTURE (82009-131), MANUFACTURE (82009-132), MANUFACTURE (82009-133), MANUFACTURE (82009-134)

Revised: 08/2023 Quallent Pharmaceuticals Health LLC