LAMOTRIGINE- lamotirigine tablet, extended release 
Zydus Lifesciences Limited

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LAMOTRIGINE Extended-release Tablets

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1514-3

Lamotrigine extended-release tablets, 25 mg

Rx only

30 tablets

25 mg label

NDC 70771-1515-3

Lamotrigine extended-release tablets, 50 mg

Rx only

30 tablets

50 mg label

NDC 70771-1516-3

Lamotrigine extended-release tablets, 100 mg

Rx only

30 tablets

100 mg label

NDC 70771-1517-3

Lamotrigine extended-release tablets, 200 mg

Rx only

30 tablets

200 mg label

NDC 70771-1518-3

Lamotrigine extended-release tablets, 250 mg

Rx only

30 tablets

250 mg label

NDC 70771-1519-3

Lamotrigine extended-release tablets, 300 mg

Rx only

30 tablets

300 mg label
LAMOTRIGINE 
lamotirigine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1514
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (LIGHT YELLOW TO YELLOW) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 979
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1514-330 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
2NDC:70771-1514-990 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
3NDC:70771-1514-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
4NDC:70771-1514-410 in 1 CARTON05/14/2020
4NDC:70771-1514-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776305/14/2020
LAMOTRIGINE 
lamotirigine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1515
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE50 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREEN (LIGHT GREEN TO GREEN) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 980
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1515-330 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
2NDC:70771-1515-990 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
3NDC:70771-1515-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
4NDC:70771-1515-410 in 1 CARTON05/14/2020
4NDC:70771-1515-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776305/14/2020
LAMOTRIGINE 
lamotirigine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1516
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGE (LIGHT ORANGE TO ORANGE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code 981
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1516-330 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
2NDC:70771-1516-990 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
3NDC:70771-1516-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
4NDC:70771-1516-410 in 1 CARTON05/14/2020
4NDC:70771-1516-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776305/14/2020
LAMOTRIGINE 
lamotirigine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1517
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUE (LIGHT BLUE TO BLUE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code 982
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1517-330 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
2NDC:70771-1517-990 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
3NDC:70771-1517-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
4NDC:70771-1517-410 in 1 CARTON05/14/2020
4NDC:70771-1517-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776305/14/2020
LAMOTRIGINE 
lamotirigine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1518
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE250 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLE (LIGHT PURPLE TO PURPLE) Scoreno score
ShapeOVAL (OVAL) Size16mm
FlavorImprint Code 983
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1518-330 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
2NDC:70771-1518-990 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
3NDC:70771-1518-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
4NDC:70771-1518-410 in 1 CARTON05/14/2020
4NDC:70771-1518-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776305/14/2020
LAMOTRIGINE 
lamotirigine tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1519
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE300 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGRAY (LIGHT GRAY TO GRAY) Scoreno score
ShapeOVAL (OVAL) Size16mm
FlavorImprint Code 984
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1519-330 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
2NDC:70771-1519-990 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
3NDC:70771-1519-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
4NDC:70771-1519-410 in 1 CARTON05/14/2020
4NDC:70771-1519-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776305/14/2020
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(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)

Revised: 10/2023
Document Id: 7a313df4-d238-43c3-a5e2-e68e45624a7b
Set id: ecb7a528-699f-4e51-9887-dee60456da2f
Version: 4
Effective Time: 20231003
 
Zydus Lifesciences Limited