Lamotrigine (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-979-06

Lamotrigine extended-release tablets, 25 mg

Rx only

30 tablets

Zydus

NDC 68382-980-06

Lamotrigine extended-release tablets, 50 mg

Rx only

30 tablets

Zydus

NDC 68382-981-06

Lamotrigine extended-release tablets, 100 mg

Rx only

30 tablets

Zydus

NDC 68382-982-06

Lamotrigine extended-release tablets, 200 mg

Rx only

30 tablets

Zydus

NDC 68382-983-06

Lamotrigine extended-release tablets, 250 mg

Rx only

30 tablets

Zydus

NDC 68382-984-06

Lamotrigine extended-release tablets, 300 mg

Rx only

30 tablets

Zydus

LAMOTRIGINE lamotrigine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-980 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 D&C YELLOW NO. 10 FD&C BLUE NO. 2 FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE TRIETHYL CITRATE WATER

Product Characteristics Color GREEN (LIGHT GREEN TO GREEN) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 980 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68382-980-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68382-980-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68382-980-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None 4 NDC:68382-980-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-980-30) 4 NDC:68382-980-30 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (68382-980-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207763 05/14/2020

LAMOTRIGINE lamotrigine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-981 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 D&C RED NO. 27 D&C YELLOW NO. 10 FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE TRIETHYL CITRATE WATER

Product Characteristics Color ORANGE (LIGHT ORANGE TO ORANGE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code 981 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68382-981-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68382-981-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68382-981-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None 4 NDC:68382-981-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-981-30) 4 NDC:68382-981-30 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (68382-981-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207763 05/14/2020

LAMOTRIGINE lamotrigine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-982 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 FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE TRIETHYL CITRATE WATER

Product Characteristics Color BLUE (LIGHT BLUE TO BLUE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code 982 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68382-982-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68382-982-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68382-982-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None 4 NDC:68382-982-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-982-30) 4 NDC:68382-982-30 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (68382-982-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207763 05/14/2020

LAMOTRIGINE lamotrigine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-983 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 CARMINIC ACID FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE TRIETHYL CITRATE WATER

Product Characteristics Color PURPLE (LIGHT PURPLE TO PURPLE) Score no score Shape OVAL (OVAL) Size 16mm Flavor Imprint Code 983 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68382-983-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68382-983-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68382-983-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None 4 NDC:68382-983-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-983-30) 4 NDC:68382-983-30 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (68382-983-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207763 05/14/2020

LAMOTRIGINE lamotrigine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-984 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 300 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE TRIETHYL CITRATE WATER

Product Characteristics Color GRAY (LIGHT GRAY TO GRAY) Score no score Shape OVAL (OVAL) Size 16mm Flavor Imprint Code 984 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68382-984-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68382-984-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68382-984-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None 4 NDC:68382-984-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-984-30) 4 NDC:68382-984-30 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (68382-984-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207763 05/14/2020

LAMOTRIGINE lamotrigine tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-979 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 D&C YELLOW NO. 10 FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER

Product Characteristics Color YELLOW (YELLOW TO LIGHT YELLOW) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 979 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68382-979-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68382-979-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68382-979-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None 4 NDC:68382-979-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-979-30) 4 NDC:68382-979-30 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (68382-979-77)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207763 05/14/2020

Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)

Registrant — Zydus Pharmaceuticals (USA) Inc. (156861945)

Establishment
Name	Address	ID/FEI	Operations
Cadila Healthcare Limited		863362789	ANALYSIS (68382-979), ANALYSIS (68382-980), ANALYSIS (68382-981), ANALYSIS (68382-982), ANALYSIS (68382-983), ANALYSIS (68382-984), MANUFACTURE (68382-979), MANUFACTURE (68382-980), MANUFACTURE (68382-981), MANUFACTURE (68382-982), MANUFACTURE (68382-983), MANUFACTURE (68382-984)

Revised: 06/2021 Zydus Pharmaceuticals (USA) Inc.