Label: BOSENTAN tablet

  • NDC Code(s): 70771-1017-1, 70771-1017-2, 70771-1017-4, 70771-1017-5, view more
    70771-1017-6, 70771-1017-8, 70771-1018-1, 70771-1018-2, 70771-1018-4, 70771-1018-5, 70771-1018-6, 70771-1018-8
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 14, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1017-6

    Bosentan tablets, 62.5 mg

    60 tablets

    Rx only

    Bosentan tablets

    NDC 70771-1018-6

    Bosentan tablets, 125 mg

    60 tablets

    Rx only

    Bosentan tablets
  • INGREDIENTS AND APPEARANCE
    BOSENTAN 
    bosentan tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1017
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BOSENTAN (UNII: Q326023R30) (BOSENTAN ANHYDROUS - UNII:XUL93R30K2) BOSENTAN ANHYDROUS62.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorPINK (LIGHT PINK) Scoreno score
    ShapeROUND (BICONVEX) Size7mm
    FlavorImprint Code 446
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1017-660 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    2NDC:70771-1017-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    3NDC:70771-1017-8180 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    4NDC:70771-1017-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    5NDC:70771-1017-410 in 1 CARTON05/01/2019
    5NDC:70771-1017-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20776005/01/2019
    BOSENTAN 
    bosentan tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1018
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BOSENTAN (UNII: Q326023R30) (BOSENTAN ANHYDROUS - UNII:XUL93R30K2) BOSENTAN ANHYDROUS125 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorPINK (LIGHT PINK) Scoreno score
    ShapeOVAL (BICONVEX) Size11mm
    FlavorImprint Code 447
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1018-660 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    2NDC:70771-1018-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    3NDC:70771-1018-8180 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    4NDC:70771-1018-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    5NDC:70771-1018-410 in 1 CARTON05/01/2019
    5NDC:70771-1018-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20776005/01/2019
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1017, 70771-1018) , MANUFACTURE(70771-1017, 70771-1018)