Label: ATORVASTATIN CALCIUM tablet

  • NDC Code(s): 70771-1443-0, 70771-1443-1, 70771-1443-3, 70771-1443-4, view more
    70771-1443-5, 70771-1443-9, 70771-1444-0, 70771-1444-1, 70771-1444-3, 70771-1444-4, 70771-1444-5, 70771-1444-9, 70771-1445-0, 70771-1445-1, 70771-1445-3, 70771-1445-4, 70771-1445-5, 70771-1445-9, 70771-1446-0, 70771-1446-1, 70771-1446-3, 70771-1446-4, 70771-1446-5, 70771-1446-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 31, 2022

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  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    NDC 70771-1443-3

    Atorvastatin Calcium Tablets, USP 10 mg

    Rx Only

    30 Tablets

    Atorvastatin Calcium Tablets, 10 mg

    NDC 70771-1444-3

    Atorvastatin Calcium Tablets, USP 20 mg

    Rx Only

    30 Tablets

    Atorvastatin Calcium Tablets, 20 mg

    NDC 70771-1445-3

    Atorvastatin Calcium Tablets, USP 40 mg

    Rx Only

    30 Tablets

    Atorvastatin Calcium Tablets, 40 mg

    NDC 70771-1446-3

    Atorvastatin Calcium Tablets, USP 80 mg

    Rx Only

    30 Tablets

    Atorvastatin Calcium Tablets, 80 mg
  • INGREDIENTS AND APPEARANCE
    ATORVASTATIN CALCIUM 
    atorvastatin calcium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1443
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVAL (OVAL) Size9mm
    FlavorImprint Code 249
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1443-410 in 1 CARTON11/21/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70771-1443-330 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    3NDC:70771-1443-990 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    4NDC:70771-1443-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    5NDC:70771-1443-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    6NDC:70771-1443-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653611/21/2018
    ATORVASTATIN CALCIUM 
    atorvastatin calcium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1444
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code 250
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1444-990 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    2NDC:70771-1444-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    3NDC:70771-1444-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    4NDC:70771-1444-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    5NDC:70771-1444-410 in 1 CARTON11/21/2018
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:70771-1444-330 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653611/21/2018
    ATORVASTATIN CALCIUM 
    atorvastatin calcium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1445
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN40 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE SODIUM PHOSPHATE (UNII: E6S1NJ4Y5Q)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVAL (OVAL) Size14mm
    FlavorImprint Code 251
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1445-990 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    2NDC:70771-1445-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    3NDC:70771-1445-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    4NDC:70771-1445-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    5NDC:70771-1445-410 in 1 CARTON11/21/2018
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:70771-1445-330 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653611/21/2018
    ATORVASTATIN CALCIUM 
    atorvastatin calcium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1446
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeOVAL (OVAL) Size19mm
    FlavorImprint Code 252
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1446-990 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    2NDC:70771-1446-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    3NDC:70771-1446-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    4NDC:70771-1446-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    5NDC:70771-1446-410 in 1 CARTON11/21/2018
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:70771-1446-330 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653611/21/2018
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1443, 70771-1444, 70771-1445, 70771-1446) , MANUFACTURE(70771-1443, 70771-1444, 70771-1445, 70771-1446)
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