Label: ATAZANAVIR capsule

  • NDC Code(s): 70771-1591-1, 70771-1591-6, 70771-1592-1, 70771-1592-6, view more
    70771-1593-1, 70771-1593-3
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated June 6, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1591-6 in bottle of 60 Capsules

    Atazanavir Capsules, 150 mg

    Rx only

    60 Capsules

    150 mg label

    NDC 70771-1592-6 in bottle of 60 Capsules

    Atazanavir Capsules, 200 mg

    Rx only

    60 Capsules

    200 mg label

    NDC 70771-1593-3 in bottle of 30 Capsules

    Atazanavir Capsules, 300 mg

    Rx only

    30 Capsules

    300 mg label
  • INGREDIENTS AND APPEARANCE
    ATAZANAVIR 
    atazanavir capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1591
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S) ATAZANAVIR150 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorBLUE (opaque blue) , GRAY (grey opaque) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 1050
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1591-660 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
    2NDC:70771-1591-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21057505/04/2021
    ATAZANAVIR 
    atazanavir capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1592
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S) ATAZANAVIR200 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorBLUE (opaque blue) , BLUE (blue opaque) Scoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code 1051
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1592-660 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
    2NDC:70771-1592-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21057505/04/2021
    ATAZANAVIR 
    atazanavir capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1593
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S) ATAZANAVIR300 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColorORANGE (orange opaque) , BLUE (blue opaque) Scoreno score
    ShapeCAPSULESize24mm
    FlavorImprint Code 1052
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1593-330 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
    2NDC:70771-1593-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21057505/04/2021
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (863362789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1591, 70771-1592, 70771-1593) , MANUFACTURE(70771-1591, 70771-1592, 70771-1593)