Label: PINDOLOL tablet

  • NDC Code(s): 70771-1134-1, 70771-1135-1
  • 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

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1134-1 in bottle of 100 Tablets

    Pindolol Tablets USP, 5 mg

    Rx only

    100 Tablets

    container label of 100 tablets - 5 mg

    NDC 70771-1135-1 in bottle of 100 Tablets

    Pindolol Tablets USP, 10 mg

    Rx only

    100 Tablets

    container label of 100 tablets - 10 mg
  • INGREDIENTS AND APPEARANCE
    PINDOLOL 
    pindolol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1134
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PINDOLOL (UNII: BJ4HF6IU1D) (PINDOLOL - UNII:BJ4HF6IU1D) PINDOLOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorWHITE (OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code 10;63
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1134-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20986611/07/2017
    PINDOLOL 
    pindolol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1135
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PINDOLOL (UNII: BJ4HF6IU1D) (PINDOLOL - UNII:BJ4HF6IU1D) PINDOLOL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorWHITE (OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 10;64
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1135-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20986611/07/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1134, 70771-1135) , MANUFACTURE(70771-1134, 70771-1135)