Label: LAMOTRIGINE- lamotirigine tablet, extended release

  • NDC Code(s): 70771-1514-2, 70771-1514-3, 70771-1514-4, 70771-1514-5, view more
    70771-1514-9, 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: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 4, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • 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
  • INGREDIENTS AND APPEARANCE
    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 - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (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 - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (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 - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (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 - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (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 - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (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 - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (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 - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare 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)