Label: LAMOTRIGINE tablet
LAMOTRIGINE tablet, chewable

  • NDC Code(s): 65841-682-01, 65841-682-05, 65841-682-10, 65841-682-11, view more
    65841-682-16, 65841-683-01, 65841-683-05, 65841-683-10, 65841-683-16, 65841-684-01, 65841-684-05, 65841-684-10, 65841-684-16, 65841-685-05, 65841-685-14, 65841-685-16, 65841-686-05, 65841-686-14, 65841-686-16, 65841-687-05, 65841-687-14, 65841-687-16, 65841-689-01, 65841-689-05, 65841-689-16, 65841-690-01, 65841-690-05, 65841-690-16
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 31, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Lamotrigine Tablets (Chewable, Dispersible), 5 mg

    NDC 65841-689-01 in bottle of 100 tablets

    100 tablets

    Rx only

    Lamotrigine Tablets (Chewable, Dispersible), 5 mg

							Lamotrigine Tablets (Chewable, Dispersible), 5mg

    Lamotrigine Tablets (Chewable, Dispersible), 5 mg

    Lamotrigine Tablets (Chewable, Dispersible), 25 mg

    NDC 65841-690-01 in bottle of 100 tablets

    100 tablets

    Rx only

    Lamotrigine Tablets (Chewable, Dispersible), 25 mg

    Lamotrigine Tablets (Chewable, Dispersible), 25 mg

    Lamotrigine Tablets USP, 25 mg

    NDC 65841-682-01 in bottle of 100 tablets

    100 tablets

    Rx only

    Lamotrigine Tablets USP, 25 mg

    Lamotrigine Tablets USP, 25 mg

    Lamotrigine Tablets USP, 50 mg

    NDC 65841-683-01 in bottle of 100 tablets

    100 tablets

    Rx only

    Lamotrigine Tablets USP, 50 mg

    Lamotrigine Tablets USP, 50 mg

    Lamotrigine Tablets USP, 100 mg

    NDC 65841-684-01 in bottle of 100 tablets

    100 tablets

    Rx only

    Lamotrigine Tablets USP, 100 mg

    Lamotrigine Tablets USP, 100 mg

    Lamotrigine Tablets USP, 150 mg

    NDC 65841-685-14 in bottle of 60 tablets

    60 tablets

    Rx only

    Lamotrigine Tablets USP, 150 mg

    Lamotrigine Tablets USP, 150 mg

    Lamotrigine Tablets USP, 200 mg

    NDC 65841-686-14 in bottle of 60 tablets

    60 tablets

    Rx only

    Lamotrigine Tablets USP, 200 mg

    Lamotrigine Tablets USP, 200 mg

    Lamotrigine Tablets USP, 250 mg

    NDC 65841-687-05 in bottle of 500 tablets

    500 tablets

    Rx only

    Lamotrigine Tablets USP, 250 mg

    Lamotrigine Tablets USP, 250 mg

  • INGREDIENTS AND APPEARANCE
    LAMOTRIGINE 
    lamotrigine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-682
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Score2 pieces
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZC;79
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-682-1125 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    2NDC:65841-682-1690 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    3NDC:65841-682-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    4NDC:65841-682-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    5NDC:65841-682-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07763301/27/2009
    LAMOTRIGINE 
    lamotrigine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-683
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Score2 pieces
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZC;90
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-683-1690 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    2NDC:65841-683-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    3NDC:65841-683-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    4NDC:65841-683-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07763301/27/2009
    LAMOTRIGINE 
    lamotrigine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-684
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Score2 pieces
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZC;80
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-684-1690 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    2NDC:65841-684-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    3NDC:65841-684-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    4NDC:65841-684-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07763301/27/2009
    LAMOTRIGINE 
    lamotrigine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-685
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Score2 pieces
    ShapeROUND (ROUND) Size11mm
    FlavorImprint Code ZC;81
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-685-1460 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    2NDC:65841-685-1690 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    3NDC:65841-685-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07763301/27/2009
    LAMOTRIGINE 
    lamotrigine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-686
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Score2 pieces
    ShapeROUND (ROUND) Size13mm
    FlavorImprint Code ZC;82
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-686-1460 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    2NDC:65841-686-1690 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    3NDC:65841-686-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07763301/27/2009
    LAMOTRIGINE 
    lamotrigine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-687
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Score2 pieces
    ShapeROUND (ROUND) Size13mm
    FlavorImprint Code ZC;91
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-687-1460 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    2NDC:65841-687-1690 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    3NDC:65841-687-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/27/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07763301/27/2009
    LAMOTRIGINE 
    lamotrigine tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-689
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BLACK CURRANT (UNII: 9755T40D11)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Score2 pieces
    ShapeROUND (ROUND) Size10mm
    FlavorBERRY (Black Current) Imprint Code Z;13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-689-1690 in 1 BOTTLE; Type 0: Not a Combination Product01/23/2009
    2NDC:65841-689-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/23/2009
    3NDC:65841-689-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07800901/23/2009
    LAMOTRIGINE 
    lamotrigine tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-690
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS) LAMOTRIGINE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BLACK CURRANT (UNII: 9755T40D11)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorBERRY (Black Current) Imprint Code Z;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-690-1690 in 1 BOTTLE; Type 0: Not a Combination Product01/23/2009
    2NDC:65841-690-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/23/2009
    3NDC:65841-690-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07800901/23/2009
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-682, 65841-683, 65841-684, 65841-685, 65841-686, 65841-687, 65841-689, 65841-690) , MANUFACTURE(65841-682, 65841-683, 65841-684, 65841-685, 65841-686, 65841-687, 65841-689, 65841-690)