Label: LAMOTRIGINE- lamotirigine tablet, extended release
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NDC Code(s):
70771-1514-2,
70771-1514-3,
70771-1514-4,
70771-1514-5, view more70771-1514-9, 70771-1515-2, 70771-1515-3, 70771-1515-4, 70771-1515-5, 70771-1515-9, 70771-1516-2, 70771-1516-3, 70771-1516-4, 70771-1516-5, 70771-1516-9, 70771-1517-2, 70771-1517-3, 70771-1517-4, 70771-1517-5, 70771-1517-9, 70771-1518-2, 70771-1518-3, 70771-1518-4, 70771-1518-5, 70771-1518-9, 70771-1519-2, 70771-1519-3, 70771-1519-4, 70771-1519-5, 70771-1519-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 3, 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 extended-release tablets, 25 mg
Rx only
30 tablets
Lamotrigine extended-release tablets, 50 mg
Rx only
30 tablets
Lamotrigine extended-release tablets, 100 mg
Rx only
30 tablets
Lamotrigine extended-release tablets, 200 mg
Rx only
30 tablets
Lamotrigine extended-release tablets, 250 mg
Rx only
30 tablets
Lamotrigine extended-release tablets, 300 mg
Rx only
30 tablets
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INGREDIENTS AND APPEARANCE
LAMOTRIGINE
lamotirigine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1514 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) 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 Marketing Start Date Marketing End Date 1 NDC:70771-1514-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 2 NDC:70771-1514-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 3 NDC:70771-1514-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 4 NDC:70771-1514-4 10 in 1 CARTON 05/14/2020 4 NDC:70771-1514-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207763 05/14/2020 LAMOTRIGINE
lamotirigine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1515 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) 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 Marketing Start Date Marketing End Date 1 NDC:70771-1515-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 2 NDC:70771-1515-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 3 NDC:70771-1515-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 4 NDC:70771-1515-4 10 in 1 CARTON 05/14/2020 4 NDC:70771-1515-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207763 05/14/2020 LAMOTRIGINE
lamotirigine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1516 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) D&C RED NO. 27 (UNII: 2LRS185U6K) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) 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 Marketing Start Date Marketing End Date 1 NDC:70771-1516-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 2 NDC:70771-1516-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 3 NDC:70771-1516-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 4 NDC:70771-1516-4 10 in 1 CARTON 05/14/2020 4 NDC:70771-1516-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207763 05/14/2020 LAMOTRIGINE
lamotirigine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1517 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) 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 Marketing Start Date Marketing End Date 1 NDC:70771-1517-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 2 NDC:70771-1517-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 3 NDC:70771-1517-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 4 NDC:70771-1517-4 10 in 1 CARTON 05/14/2020 4 NDC:70771-1517-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207763 05/14/2020 LAMOTRIGINE
lamotirigine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1518 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) CARMINIC ACID (UNII: CID8Z8N95N) 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 Marketing Start Date Marketing End Date 1 NDC:70771-1518-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 2 NDC:70771-1518-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 3 NDC:70771-1518-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 4 NDC:70771-1518-4 10 in 1 CARTON 05/14/2020 4 NDC:70771-1518-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207763 05/14/2020 LAMOTRIGINE
lamotirigine tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1519 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE 300 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 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 Marketing Start Date Marketing End Date 1 NDC:70771-1519-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 2 NDC:70771-1519-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 3 NDC:70771-1519-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/14/2020 4 NDC:70771-1519-4 10 in 1 CARTON 05/14/2020 4 NDC:70771-1519-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 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 Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1514, 70771-1515, 70771-1516, 70771-1517, 70771-1518, 70771-1519) , MANUFACTURE(70771-1514, 70771-1515, 70771-1516, 70771-1517, 70771-1518, 70771-1519)