Label: CHLORTHALIDONE tablet

  • NDC Code(s): 70771-1369-0, 70771-1369-1, 70771-1370-0, 70771-1370-1
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 28, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1369-1

    Chlorthalidone tablets USP ,25 mg

    Rx only

    100 tablets

    Chlorthalidone tablets, USP

    NDC 70771-1370-1

    Chlorthalidone tablets USP, 50 mg

    Rx only

    100 tablets

    Chlorthalidone tablets, USP
  • INGREDIENTS AND APPEARANCE
    CHLORTHALIDONE 
    chlorthalidone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1369
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q) CHLORTHALIDONE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code Z25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1369-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2019
    2NDC:70771-1369-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20781305/15/2019
    CHLORTHALIDONE 
    chlorthalidone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1370
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORTHALIDONE (UNII: Q0MQD1073Q) (CHLORTHALIDONE - UNII:Q0MQD1073Q) CHLORTHALIDONE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITE (WHITE) Score2 pieces
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code Z;50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1370-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2019
    2NDC:70771-1370-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20781305/15/2019
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1369, 70771-1370) , MANUFACTURE(70771-1369, 70771-1370)