Label: ROSUVASTATIN tablet, film coated

  • NDC Code(s): 70771-1481-0, 70771-1481-1, 70771-1481-2, 70771-1481-3, view more
    70771-1481-5, 70771-1481-9, 70771-1482-0, 70771-1482-1, 70771-1482-2, 70771-1482-3, 70771-1482-5, 70771-1482-9, 70771-1483-0, 70771-1483-1, 70771-1483-2, 70771-1483-3, 70771-1483-5, 70771-1483-9, 70771-1484-0, 70771-1484-1, 70771-1484-2, 70771-1484-3, 70771-1484-5, 70771-1484-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 9, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1481-3

    Rosuvastatin Calcium Tablets, 5 mg

    30 Tablets

    Rx only

    Rosuvastatin Ca Tablets

    NDC 70771-1482-3

    Rosuvastatin Calcium Tablets, 10 mg

    30 Tablets

    Rx only

    Rosuvastatin Ca Tablets

    NDC 70771-1483-3

    Rosuvastatin Calcium Tablets, 20 mg

    30 Tablets

    Rx only

    Rosuvastatin Ca Tablets

    NDC 70771-1484-3

    Rosuvastatin Calcium Tablets, 40 mg

    30 Tablets

    Rx only

    Rosuvastatin Ca Tablets
  • INGREDIENTS AND APPEARANCE
    ROSUVASTATIN 
    rosuvastatin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1481
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73) ROSUVASTATIN5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorYELLOW (YELLOW) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 627
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1481-330 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    2NDC:70771-1481-990 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    3NDC:70771-1481-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    4NDC:70771-1481-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    5NDC:70771-1481-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    6NDC:70771-1481-210 in 1 CARTON01/16/202007/09/2022
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20651301/16/202007/09/2022
    ROSUVASTATIN 
    rosuvastatin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1482
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73) ROSUVASTATIN10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorPINK (PINK) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 628
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1482-330 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    2NDC:70771-1482-990 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    3NDC:70771-1482-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    4NDC:70771-1482-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    5NDC:70771-1482-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    6NDC:70771-1482-210 in 1 CARTON01/16/202007/09/2022
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20651301/16/202007/09/2022
    ROSUVASTATIN 
    rosuvastatin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1483
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73) ROSUVASTATIN20 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGE (ORANGE) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code 629
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1483-330 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2020
    2NDC:70771-1483-990 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2020
    3NDC:70771-1483-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2020
    4NDC:70771-1483-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2020
    5NDC:70771-1483-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2020
    6NDC:70771-1483-210 in 1 CARTON01/16/2020
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20651301/16/2020
    ROSUVASTATIN 
    rosuvastatin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1484
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73) ROSUVASTATIN40 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorPURPLE (LIGHT PURPLE) Scoreno score
    ShapeOVAL (OVAL) Size16mm
    FlavorImprint Code 630
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1484-330 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    2NDC:70771-1484-990 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    3NDC:70771-1484-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    4NDC:70771-1484-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    5NDC:70771-1484-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
    6NDC:70771-1484-210 in 1 CARTON01/16/202007/09/2022
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20651301/16/202007/09/2022
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1481, 70771-1482, 70771-1483, 70771-1484) , MANUFACTURE(70771-1481, 70771-1482, 70771-1483, 70771-1484)
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