GALANTAMINE- galantamine tablet, film coated 
Cadila Healthcare Limited

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GALANTAMINE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-755-14 in bottle of 60 tablets

Galantamine Tablets USP, 4 mg

Rx only

60 tablets

galantamine tablets USP, 4mg

NDC 65841-756-14 in bottle of 60 tablets

Galantamine Tablets USP, 8 mg

Rx only

60 tablets

galantamine Tablets USP, 8mg

NDC 65841-757-14 in bottle of 60 tablets

Galantamine Tablets USP, 12 mg

Rx only

60 tablets

galantamine Tablets USP, 12mg
GALANTAMINE 
galantamine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-755
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA) GALANTAMINE4 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
Product Characteristics
ColorPINK (LIGHT PINK) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code 77;Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-755-1460 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2011
2NDC:65841-755-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2011
3NDC:65841-755-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2011
4NDC:65841-755-7710 in 1 CARTON10/10/2011
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07889810/10/2011
GALANTAMINE 
galantamine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-756
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA) GALANTAMINE8 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 78;Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-756-1460 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2011
2NDC:65841-756-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2011
3NDC:65841-756-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2011
4NDC:65841-756-7710 in 1 CARTON10/10/2011
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07889810/10/2011
GALANTAMINE 
galantamine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-757
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA) GALANTAMINE12 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
ColorWHITE (OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code 79;Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-757-1460 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2011
2NDC:65841-757-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2011
3NDC:65841-757-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2011
4NDC:65841-757-7710 in 1 CARTON10/10/2011
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07889810/10/2011
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-755, 65841-756, 65841-757) , MANUFACTURE(65841-755, 65841-756, 65841-757)

Revised: 8/2020
Document Id: c295f9c6-58ea-42be-91f5-5e19b001e51e
Set id: 63bad97b-3df6-4e8f-b183-95f1e9801c8f
Version: 6
Effective Time: 20200826
 
Cadila Healthcare Limited