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

Lamotrigine extended-release tablets
(click image for full-size original)

NDC 68382-980-06

Lamotrigine extended-release tablets, 50 mg

Rx only

30 tablets

Zydus

Lamotrigine extended-release tablets
(click image for full-size original)

NDC 68382-981-06

Lamotrigine extended-release tablets, 100 mg

Rx only

30 tablets

Zydus

Lamotrigine extended-release tablets
(click image for full-size original)

NDC 68382-982-06

Lamotrigine extended-release tablets, 200 mg

Rx only

30 tablets

Zydus

Lamotrigine extended-release tablets
(click image for full-size original)

NDC 68382-983-06

Lamotrigine extended-release tablets, 250 mg

Rx only

30 tablets

Zydus

Lamotrigine extended-release tablets
(click image for full-size original)

NDC 68382-984-06

Lamotrigine extended-release tablets, 300 mg

Rx only

30 tablets

Zydus

Lamotrigine extended-release tablets
(click image for full-size original)
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.

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