Label: CARVEDILOL tablet, film coated

  • NDC Code(s): 65841-616-01, 65841-616-05, 65841-616-17, 65841-617-01, view more
    65841-617-05, 65841-617-17, 65841-618-01, 65841-618-05, 65841-618-17, 65841-619-01, 65841-619-05, 65841-619-17
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 31, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-616-01 in bottle of 100 Tablets

    Carvedilol Tablets USP, 3.125 mg

    Rx only

    100 Tablets

    Carvedilol Tablets, 3.125 mg

    NDC 65841-617-01 in bottle of 100 Tablets

    Carvedilol Tablets USP, 6.25 mg

    Rx only

    100 Tablets

    Carvedilol Tablets, 6.25 mg

    NDC 65841-618-01 in bottle of 100 Tablets

    Carvedilol Tablets USP, 12.5 mg

    Rx only

    100 Tablets

    Carvedilol Tablets, 12.5 mg

    NDC 65841-619-01 in bottle of 100 Tablets

    Carvedilol Tablets USP, 25 mg

    Rx only

    100 Tablets

    Carvedilol Tablets,25 mg
  • INGREDIENTS AND APPEARANCE
    CARVEDILOL 
    carvedilol tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-616
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL3.125 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size4mm
    FlavorImprint Code Z;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-616-1728 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    2NDC:65841-616-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    3NDC:65841-616-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07761409/05/2007
    CARVEDILOL 
    carvedilol tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-617
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZC40
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-617-1728 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    2NDC:65841-617-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    3NDC:65841-617-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07761409/05/2007
    CARVEDILOL 
    carvedilol tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-618
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code ZC41
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-618-1728 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    2NDC:65841-618-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    3NDC:65841-618-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07761409/05/2007
    CARVEDILOL 
    carvedilol tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-619
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZC42
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-619-1728 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    2NDC:65841-619-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    3NDC:65841-619-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/05/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07761409/05/2007
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-616, 65841-617, 65841-618, 65841-619) , MANUFACTURE(65841-616, 65841-617, 65841-618, 65841-619)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited677605858ANALYSIS(65841-616, 65841-617, 65841-618, 65841-619) , MANUFACTURE(65841-616, 65841-617, 65841-618, 65841-619)
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