Label: NADOLOL tablet

  • NDC Code(s): 70771-1089-0, 70771-1089-1, 70771-1089-2, 70771-1089-4, view more
    70771-1089-9, 70771-1090-0, 70771-1090-1, 70771-1090-2, 70771-1090-4, 70771-1090-9, 70771-1091-0, 70771-1091-1, 70771-1091-2, 70771-1091-4, 70771-1091-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 29, 2024

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1089-1

    Nadolol tablets, 20 mg

    Rx only

    100 tablets

    Nadolol tablets

    NDC 70771-1090-1

    Nadolol tablets, 40 mg

    Rx only

    100 tablets

    Nadolol tablets

    NDC 70771-1091-1

    Nadolol tablets, 80 mg

    Rx only

    100 tablets

    Nadolol tablets
  • INGREDIENTS AND APPEARANCE
    NADOLOL 
    nadolol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1090
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V) NADOLOL40 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code N;40
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1090-410 in 1 CARTON08/08/2017
    1NDC:70771-1090-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70771-1090-990 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
    3NDC:70771-1090-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
    4NDC:70771-1090-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20776108/08/2017
    NADOLOL 
    nadolol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1091
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V) NADOLOL80 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorBLUE (BLUE) Score2 pieces
    ShapeROUND (ROUND) Size11mm
    FlavorImprint Code N;80
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1091-990 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
    2NDC:70771-1091-410 in 1 CARTON08/08/2017
    2NDC:70771-1091-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:70771-1091-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
    4NDC:70771-1091-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20776108/08/2017
    NADOLOL 
    nadolol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1089
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NADOLOL (UNII: FEN504330V) (NADOLOL - UNII:FEN504330V) NADOLOL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code N;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1089-990 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
    2NDC:70771-1089-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
    3NDC:70771-1089-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2017
    4NDC:70771-1089-410 in 1 CARTON08/08/2017
    4NDC:70771-1089-21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20776108/08/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1089, 70771-1090, 70771-1091) , MANUFACTURE(70771-1089, 70771-1090, 70771-1091)
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