Label: ATENOLOL tablet

  • NDC Code(s): 65841-022-01, 65841-022-10, 65841-022-16, 65841-022-24, view more
    65841-022-40, 65841-023-01, 65841-023-02, 65841-023-10, 65841-023-16, 65841-023-24, 65841-023-40, 65841-024-01, 65841-024-10, 65841-024-16, 65841-024-40
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 24, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-022-01 in bottles of 100 tablets

    Atenolol Tablets USP, 25 mg

    Rx only

    100 Tablets

    Atenolol Tablets, 25 mg

    NDC 65841-023-01 in bottles of 100 tablets

    Atenolol Tablets USP, 50 mg

    Rx only

    100 Tablets

    Atenolol Tablets, 50 mg

    NDC 65841-024-01 in bottles of 100 tablets

    Atenolol Tablets USP, 100 mg

    Rx only

    100 Tablets

    Atenolol Tablets, 100 mg
  • INGREDIENTS AND APPEARANCE
    ATENOLOL 
    atenolol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-022
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code Z;65
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-022-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    2NDC:65841-022-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    3NDC:65841-022-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    4NDC:65841-022-405000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    5NDC:65841-022-2410000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07690010/08/2005
    ATENOLOL 
    atenolol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-023
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Score2 pieces
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code Z;66
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-023-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    2NDC:65841-023-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    3NDC:65841-023-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    4NDC:65841-023-022000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    5NDC:65841-023-405000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    6NDC:65841-023-2410000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07690010/08/2005
    ATENOLOL 
    atenolol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-024
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF- WHITE) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code Z;67
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-024-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    2NDC:65841-024-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    3NDC:65841-024-405000 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    4NDC:65841-024-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07690010/08/2005
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-022, 65841-023, 65841-024) , MANUFACTURE(65841-022, 65841-023, 65841-024)
    Establishment
    NameAddressID/FEIBusiness Operations
    CADILA HEALTHCARE LIMITED677605858ANALYSIS(65841-022, 65841-023, 65841-024) , MANUFACTURE(65841-022, 65841-023, 65841-024)