Label: GALANTAMINE tablet, film coated

  • NDC Code(s): 65841-755-01, 65841-755-10, 65841-755-14, 65841-755-77, view more
    65841-756-01, 65841-756-10, 65841-756-14, 65841-756-77, 65841-757-01, 65841-757-10, 65841-757-14, 65841-757-77
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 26, 2020

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

  • SPL UNCLASSIFIED SECTION

  • 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
  • INGREDIENTS AND APPEARANCE
    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)