Label: ATENOLOL AND CHLORTHALIDONE tablet

  • NDC Code(s): 70771-1372-1, 70771-1373-1
  • 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

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1372-1

    Atenolol and Chlorthalidone Tablets, USP 50 mg/25 mg

    Rx only

    100 Tablets

    Atenolol and Chlorthalidon Tablets, USP

    NDC 70771-1373-1

    Atenolol and Chlorthalidone Tablets, USP 100 mg/25 mg

    Rx only

    100 Tablets

    Atenolol and Chlorthalidon Tablets, USP
  • INGREDIENTS AND APPEARANCE
    ATENOLOL AND CHLORTHALIDONE 
    atenolol and chlorthalidone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1372
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL50 mg
    CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q) CHLORTHALIDONE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF WHITE) Score2 pieces
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 11;67
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1372-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21002803/12/2019
    ATENOLOL AND CHLORTHALIDONE 
    atenolol and chlorthalidone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1373
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI) ATENOLOL100 mg
    CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q) CHLORTHALIDONE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF WHITE) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code 11;68
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1373-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21002803/12/2019
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1372, 70771-1373) , MANUFACTURE(70771-1372, 70771-1373)