Lamotrigine

LAMOTRIGINE- lamotrigine tablet, extended release
Zydus Lifesciences Limited

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1514-3

Lamotrigine extended-release tablets, 25 mg

Rx only

30 tablets

25 mg label
(click image for full-size original)

NDC 70771-1515-3

Lamotrigine extended-release tablets, 50 mg

Rx only

30 tablets

50 mg label
(click image for full-size original)

NDC 70771-1516-3

Lamotrigine extended-release tablets, 100 mg

Rx only

30 tablets

100 mg label
(click image for full-size original)

NDC 70771-1517-3

Lamotrigine extended-release tablets, 200 mg

Rx only

30 tablets

200 mg label
(click image for full-size original)

NDC 70771-1518-3

Lamotrigine extended-release tablets, 250 mg

Rx only

30 tablets

250 mg label
(click image for full-size original)

NDC 70771-1519-3

Lamotrigine extended-release tablets, 300 mg

Rx only

30 tablets

300 mg label
(click image for full-size original)
LAMOTRIGINE
lamotirigine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1514
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 AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TRIETHYL CITRATE
TITANIUM DIOXIDE
WATER
Product Characteristics
Color YELLOW (LIGHT YELLOW TO YELLOW) Score no score
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code 979
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1514-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1514-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1514-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:70771-1514-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1514-2)
4 NDC:70771-1514-2 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1514-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207763 05/14/2020
LAMOTRIGINE
lamotirigine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1515
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 AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TRIETHYL CITRATE
TITANIUM DIOXIDE
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:70771-1515-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1515-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1515-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:70771-1515-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1515-2)
4 NDC:70771-1515-2 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1515-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207763 05/14/2020
LAMOTRIGINE
lamotirigine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1516
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 YELLOW NO. 10
D&C RED NO. 27
FERRIC OXIDE YELLOW
GLYCERYL MONOSTEARATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TRIETHYL CITRATE
TITANIUM DIOXIDE
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:70771-1516-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1516-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1516-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:70771-1516-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1516-2)
4 NDC:70771-1516-2 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1516-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207763 05/14/2020
LAMOTRIGINE
lamotirigine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1517
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 AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TRIETHYL CITRATE
TITANIUM DIOXIDE
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:70771-1517-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1517-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1517-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:70771-1517-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1517-2)
4 NDC:70771-1517-2 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1517-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207763 05/14/2020
LAMOTRIGINE
lamotirigine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1518
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
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
GLYCERYL MONOSTEARATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TRIETHYL CITRATE
TITANIUM DIOXIDE
WATER
CARMINIC ACID
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:70771-1518-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1518-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1518-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:70771-1518-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1518-2)
4 NDC:70771-1518-2 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1518-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207763 05/14/2020
LAMOTRIGINE
lamotirigine tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1519
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
FERROSOFERRIC OXIDE
GLYCERYL MONOSTEARATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TRIETHYL CITRATE
TITANIUM DIOXIDE
WATER
FERRIC OXIDE YELLOW
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:70771-1519-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:70771-1519-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:70771-1519-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:70771-1519-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1519-2)
4 NDC:70771-1519-2 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (70771-1519-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207763 05/14/2020
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70771-1514), ANALYSIS (70771-1515), ANALYSIS (70771-1516), ANALYSIS (70771-1517), ANALYSIS (70771-1518), ANALYSIS (70771-1519), MANUFACTURE (70771-1514), MANUFACTURE (70771-1515), MANUFACTURE (70771-1516), MANUFACTURE (70771-1517), MANUFACTURE (70771-1518), MANUFACTURE (70771-1519)

Revised: 10/2023 Zydus Lifesciences Limited

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