Label: AMBRISENTAN tablet, film coated

  • NDC Code(s): 70771-1363-1, 70771-1363-3, 70771-1363-7, 70771-1363-8, view more
    70771-1363-9, 70771-1364-1, 70771-1364-3, 70771-1364-7, 70771-1364-8, 70771-1364-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated October 19, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1363-3

    Ambrisentan Tablets, 5 mg

    30 Tablets

    Rx only

    labels

    NDC 70771-1364-3

    Ambrisentan Tablets, 10 mg

    30 Tablets

    Rx only

    label
  • INGREDIENTS AND APPEARANCE
    AMBRISENTAN 
    ambrisentan tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1363
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMBRISENTAN (UNII: HW6NV07QEC) (AMBRISENTAN - UNII:HW6NV07QEC) AMBRISENTAN5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorPINK (PINK) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 1179
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1363-330 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    2NDC:70771-1363-990 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    3NDC:70771-1363-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    4NDC:70771-1363-83 in 1 CARTON04/12/2019
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:70771-1363-71 in 1 CARTON04/12/2019
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21005804/12/2019
    AMBRISENTAN 
    ambrisentan tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1364
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMBRISENTAN (UNII: HW6NV07QEC) (AMBRISENTAN - UNII:HW6NV07QEC) AMBRISENTAN10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorWHITE (OFF WHITE) Scoreno score
    ShapeOVAL (OVAL) Size10mm
    FlavorImprint Code 1180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1364-330 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    2NDC:70771-1364-990 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    3NDC:70771-1364-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2019
    4NDC:70771-1364-83 in 1 CARTON04/12/2019
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:70771-1364-71 in 1 CARTON04/12/2019
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21005804/12/2019
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1363, 70771-1364) , MANUFACTURE(70771-1363, 70771-1364)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!