Label: IVABRADINE tablet

  • NDC Code(s): 70771-1863-6, 70771-1863-8, 70771-1864-6, 70771-1864-8
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 1, 2023

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

  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Ivabradine Tablets, 5 mg

    NDC 70771-1863-6

    60 tablets

    Rx only

    5 mg

    Ivabradine Tablets, 5 mg

    NDC 70771-1864-6

    60 tablets

    Rx only

    7.5 mg
  • INGREDIENTS AND APPEARANCE
    IVABRADINE 
    ivabradine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1863
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IVABRADINE HYDROCHLORIDE (UNII: TP19837BZK) (IVABRADINE - UNII:3H48L0LPZQ) IVABRADINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScore2 pieces
    ShapeOVALSize9mm
    FlavorImprint Code 1471
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1863-660 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2024
    2NDC:70771-1863-8180 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21344207/02/2024
    IVABRADINE 
    ivabradine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1864
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IVABRADINE HYDROCHLORIDE (UNII: TP19837BZK) (IVABRADINE - UNII:3H48L0LPZQ) IVABRADINE7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 1472
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1864-660 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2024
    2NDC:70771-1864-8180 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21344207/02/2024
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1863, 70771-1864) , MANUFACTURE(70771-1863, 70771-1864)