LAMOTRIGINE- lamotrigine tablet 
LAMOTRIGINE- lamotrigine tablet, chewable 
Cadila Healthcare Limited

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LAMOTRIGINE TABLETS and LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE).

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

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)

Revised: 8/2020
Document Id: 0ec9b7eb-f15a-44a1-b499-9452df6e82df
Set id: 0f2f7421-56d4-45d0-9d2d-dc1edaede039
Version: 8
Effective Time: 20200831
 
Cadila Healthcare Limited