Label: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet, film coated
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NDC Code(s):
70771-1760-1,
70771-1760-3,
70771-1760-5,
70771-1761-1, view more70771-1761-3, 70771-1761-5, 70771-1762-1, 70771-1762-3, 70771-1762-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 7, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 2.5 mg/6.25 mg
30 Tablets Unit-of-Use
Rx only
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 5 mg/6.25 mg
30 Tablets Unit-of-Use
Rx only
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 10 mg/6.25 mg
30 Tablets Unit-of-Use
Rx only
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INGREDIENTS AND APPEARANCE
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
bisoprolol fumarate and hydrochlorothiazide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1760 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U) BISOPROLOL FUMARATE 2.5 mg HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 6.25 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color YELLOW (with occasional greyish to black speckles) Score no score Shape ROUND (round) Size 7mm Flavor Imprint Code 113 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1760-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 2 NDC:70771-1760-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 3 NDC:70771-1760-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215666 03/01/2023 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
bisoprolol fumarate and hydrochlorothiazide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1761 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 HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 6.25 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color PINK (light pink to pink) Score no score Shape ROUND (round) Size 7mm Flavor Imprint Code 114 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1761-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 2 NDC:70771-1761-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 3 NDC:70771-1761-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215666 03/01/2023 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
bisoprolol fumarate and hydrochlorothiazide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1762 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 HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 6.25 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) Product Characteristics Color WHITE (with occasional greyish to black speckles) Score no score Shape ROUND (round) Size 7mm Flavor Imprint Code 115 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1762-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 2 NDC:70771-1762-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 3 NDC:70771-1762-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215666 03/01/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1760, 70771-1761, 70771-1762) , MANUFACTURE(70771-1760, 70771-1761, 70771-1762)