Label: DIPYRIDAMOLE tablet, film coated

  • NDC Code(s): 65841-662-01, 65841-662-05, 65841-662-10, 65841-662-77, view more
    65841-663-01, 65841-663-05, 65841-663-10, 65841-663-77, 65841-664-01, 65841-664-05, 65841-664-10, 65841-664-77
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 2, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-662-01 in bottle of 100 tablets

    Dipyridamole Tablets USP, 25 mg

    Rx only

    100 tablets

    ZYDUS

    Dipyridamole Tablets, 25 mg

    NDC 65841-663-01 in bottle of 100 tablets

    Dipyridamole Tablets USP, 50 mg

    Rx only

    100 tablets

    ZYDUS

    Dipyridamole Tablets, 50 mg

    NDC 65841-664-01 in bottle of 100 tablets

    Dipyridamole Tablets USP, 75 mg

    Rx only

    100 tablets

    ZYDUS

    Dipyridamole Tablets, 75 mg
  • INGREDIENTS AND APPEARANCE
    DIPYRIDAMOLE 
    dipyridamole tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-662
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZE;43
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-662-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
    2NDC:65841-662-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
    3NDC:65841-662-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
    4NDC:65841-662-7710 in 1 CARTON05/22/2008
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04087405/22/2008
    DIPYRIDAMOLE 
    dipyridamole tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-663
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZE;49
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-663-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
    2NDC:65841-663-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
    3NDC:65841-663-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
    4NDC:65841-663-7710 in 1 CARTON05/22/2008
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04087405/22/2008
    DIPYRIDAMOLE 
    dipyridamole tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-664
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C) DIPYRIDAMOLE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code ZE;50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-664-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
    2NDC:65841-664-05500 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
    3NDC:65841-664-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/22/2008
    4NDC:65841-664-7710 in 1 CARTON05/22/2008
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04087405/22/2008
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-662, 65841-663, 65841-664) , MANUFACTURE(65841-662, 65841-663, 65841-664)
    Establishment
    NameAddressID/FEIBusiness Operations
    CADILA HEALTHCARE LIMITED677605858ANALYSIS(65841-662, 65841-663, 65841-664) , MANUFACTURE(65841-662, 65841-663, 65841-664)