BISOPROLOL- bisoprolol fumarate tablet, film coated 
TruPharma, LLC

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Bisoprolol Tablets USP 5mg and 10mg

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

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

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

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

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)

Revised: 7/2019
Document Id: 16482dd5-20dc-4570-82b8-ded8b1d902c4
Set id: bba0bc2b-602f-4df1-a761-85bd3c80c7de
Version: 1
Effective Time: 20190718
 
TruPharma, LLC