Label: ZYPITAMAG- pitavastatin magnesium tablet, film coated

  • NDC Code(s): 70771-1117-0, 70771-1117-1, 70771-1117-3, 70771-1117-4, view more
    70771-1117-5, 70771-1117-7, 70771-1117-9, 70771-1118-0, 70771-1118-1, 70771-1118-3, 70771-1118-4, 70771-1118-5, 70771-1118-7, 70771-1118-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 8, 2021

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1117-9

    Zypitamag (Pitavastatin) Tablets, 2 mg

    90 Tablets

    Rx only

    image

    NDC 70771-1117-7

    Zypitamag (Pitavastatin) Tablets, 2 mg

    7 Tablets Blister Carton

    Rx only

    Professional Sample-Not For Sale

    image

    NDC 70771-1118-9

    Zypitamag (Pitavastatin) Tablets, 4 mg

    90 Tablets

    Rx only

    image

    NDC 70771-1118-7

    Zypitamag (Pitavastatin) Tablets, 4 mg

    7 Tablets Blister Carton

    Rx only

    Professional Sample-Not For Sale

    image
  • INGREDIENTS AND APPEARANCE
    ZYPITAMAG 
    pitavastatin magnesium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PITAVASTATIN (UNII: M5681Q5F9P) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (off white) Scoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 877
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1117-330 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    2NDC:70771-1117-990 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    3NDC:70771-1117-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    4NDC:70771-1117-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    5NDC:70771-1117-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    6NDC:70771-1117-410 in 1 CARTON03/09/2018
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:70771-1117-71 in 1 CARTON03/09/2018
    77 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20837903/09/2018
    ZYPITAMAG 
    pitavastatin magnesium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PITAVASTATIN (UNII: M5681Q5F9P) (PITAVASTATIN - UNII:M5681Q5F9P) PITAVASTATIN4 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (off white) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 878
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1118-330 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    2NDC:70771-1118-990 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    3NDC:70771-1118-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    4NDC:70771-1118-5500 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    5NDC:70771-1118-01000 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
    6NDC:70771-1118-410 in 1 CARTON03/09/2018
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:70771-1118-71 in 1 CARTON03/09/2018
    77 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20837903/09/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1117, 70771-1118) , MANUFACTURE(70771-1117, 70771-1118)