Label: PRAVASTATIN SODIUM tablet

  • NDC Code(s): 65841-739-05, 65841-739-16, 65841-740-05, 65841-740-10, view more
    65841-740-16, 65841-741-05, 65841-741-16, 65841-742-05, 65841-742-16
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 8, 2020

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

  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-739-05 in bottle of 500 tablets

    Pravastatin Sodium Tablets USP, 10 mg

    Rx only

    500 tablets

    Pravastatin Sodium Tablets USP, 10 mg

    NDC 65841-740-05 in bottle of 500 tablets

    Pravastatin Sodium Tablets USP, 20 mg

    Rx only

    500 tablets

    Pravastatin Sodium Tablets USP, 20 mg

    NDC 65841-741-05 in bottle of 500 tablets

    Pravastatin Sodium Tablets USP, 40 mg

    Rx only

    500 tablets

    Pravastatin Sodium Tablets, 40 mg

    NDC 65841-742-05 in bottle of 500 tablets

    Pravastatin Sodium Tablets USP, 80 mg

    Rx only

    500 tablets

    Pravastatin Sodium Tablets, 80 mg
  • INGREDIENTS AND APPEARANCE
    PRAVASTATIN SODIUM 
    pravastatin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-739
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOVAL (OVAL) Size9mm
    FlavorImprint Code ZC46
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-739-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
    2NDC:65841-739-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07775103/30/2010
    PRAVASTATIN SODIUM 
    pravastatin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-740
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code ZC45
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-740-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
    2NDC:65841-740-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
    3NDC:65841-740-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07775103/30/2010
    PRAVASTATIN SODIUM 
    pravastatin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-741
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM40 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOVAL (OVAL) Size14mm
    FlavorImprint Code ZC44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-741-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
    2NDC:65841-741-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07775103/30/2010
    PRAVASTATIN SODIUM 
    pravastatin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-742
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G) PRAVASTATIN SODIUM80 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOVAL (OVAL) Size19mm
    FlavorImprint Code ZC43
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-742-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
    2NDC:65841-742-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/30/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07775103/30/2010
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    CADILA HEALTHCARE LIMITED677605858ANALYSIS(65841-739, 65841-740, 65841-741, 65841-742) , MANUFACTURE(65841-739, 65841-740, 65841-741, 65841-742)