Label: BISOPROLOL- bisoprolol fumarate tablet, film coated

  • NDC Code(s): 52817-270-10, 52817-270-30, 52817-271-10, 52817-271-30
  • Packager: TruPharma, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated July 18, 2019

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  • Principal Display Panel

       

    NDC 52817-270-30

    Bisoprolol Fumarate Tablets, USP

    5mg

    Rx Only

    30 Tablets

    TruPharma

    Principal Display Panel
   
NDC 52817-270-30
Bisoprolol Fumarate Tablets, USP 
5mg
Rx Only
30 Tablets
TruPharma

    Close
  • Principal Display Panel

    NDC 52817-270-10

    Bisoprolol Fumarate Tablets, USP

    5mg

    Rx Only

    100 Tablets

    TruPharma

    NDC 52817-270-10
Bisoprolol Fumarate Tablets, USP 
5mg
Rx Only
100 Tablets
TruPharma

    Close
  • Principal Display Panel

      

    NDC 52817-271-30

    Bisoprolol Fumarate Tablets, USP

    10mg

    Rx Only

    30 Tablets

    TruPharma

    Principal Display Panel
  
NDC 52817-271-30
Bisoprolol Fumarate Tablets, USP 
10mg
Rx Only
30 Tablets
TruPharma

    Close
  • Principal Display Panel

      

    NDC 52817-271-10

    Bisoprolol Fumarate Tablets, USP

    10mg

    Rx Only

    100 Tablets

    TruPharma

    Principal Display Panel
  
NDC 52817-271-10
Bisoprolol Fumarate Tablets, USP 
10mg
Rx Only
100 Tablets
TruPharma

    Close
  • INGREDIENTS AND APPEARANCE
    BISOPROLOL 
    bisoprolol fumarate tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-270
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U) BISOPROLOL FUMARATE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    Color RED Score 2 pieces
    Shape ROUND Size 8mm
    Flavor Imprint Code MP;711
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52817-270-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/20/2019
    2 NDC:52817-270-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/20/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075474 06/20/2019
    BISOPROLOL 
    bisoprolol fumarate tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-271
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U) BISOPROLOL FUMARATE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code MP;712
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52817-271-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/20/2019
    2 NDC:52817-271-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/20/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075474 06/20/2019
    Labeler - TruPharma, LLC (078533947)
    Close