bisoprolol fumarate and hydrochlorothiazide (71335-0595)

Drug Facts

Product Profile

Brand Name bisoprolol fumarate and hydrochlorothiazide

Generic Name bisoprolol fumarate and hydrochlorothiazide

Labeler bryant ranch prepack

Dosage Form TABLET

Routes

ORAL

Active Ingredients

bisoprolol fumarate 5 mg/1, hydrochlorothiazide 6.25 mg/1

Manufacturer

Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0595

Product ID 71335-0595_83e47e72-5cf3-4db5-902e-20d7d9595cb9

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA079106

Listing Expiration 2026-12-31

Marketing Start 2010-10-12

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713350595

Hyphenated Format 71335-0595

Supplemental Identifiers

RxCUI

854919

UNII

UR59KN573L 0J48LPH2TH

NUI

N0000175359 N0000175419 M0471776

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bisoprolol fumarate and hydrochlorothiazide (source: ndc)

Generic Name bisoprolol fumarate and hydrochlorothiazide (source: ndc)

Application Number ANDA079106 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
6.25 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE, PLASTIC (71335-0595-1)
90 TABLET in 1 BOTTLE, PLASTIC (71335-0595-2)
28 TABLET in 1 BOTTLE, PLASTIC (71335-0595-3)
100 TABLET in 1 BOTTLE, PLASTIC (71335-0595-4)

source: ndc

Packages (4)

71335-0595-1 30 TABLET in 1 BOTTLE, PLASTIC (71335-0595-1) 71335-0595-2 90 TABLET in 1 BOTTLE, PLASTIC (71335-0595-2) 71335-0595-3 28 TABLET in 1 BOTTLE, PLASTIC (71335-0595-3) 71335-0595-4 100 TABLET in 1 BOTTLE, PLASTIC (71335-0595-4)

Ingredients (2)

bisoprolol fumarate (5 mg/1) hydrochlorothiazide (6.25 mg/1)

Linked Drug Pages (1)

bisoprolol fumarate and hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "83e47e72-5cf3-4db5-902e-20d7d9595cb9", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["UR59KN573L", "0J48LPH2TH"], "rxcui": ["854919"], "spl_set_id": ["447c11b6-72fe-418e-a2db-5d90b5347796"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (71335-0595-1)", "package_ndc": "71335-0595-1", "marketing_start_date": "20180625"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71335-0595-2)", "package_ndc": "71335-0595-2", "marketing_start_date": "20190319"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (71335-0595-3)", "package_ndc": "71335-0595-3", "marketing_start_date": "20240523"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (71335-0595-4)", "package_ndc": "71335-0595-4", "marketing_start_date": "20230719"}], "brand_name": "bisoprolol fumarate and hydrochlorothiazide", "product_id": "71335-0595_83e47e72-5cf3-4db5-902e-20d7d9595cb9", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "71335-0595", "generic_name": "bisoprolol fumarate and hydrochlorothiazide", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bisoprolol fumarate and hydrochlorothiazide", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "6.25 mg/1"}], "application_number": "ANDA079106", "marketing_category": "ANDA", "marketing_start_date": "20101012", "listing_expiration_date": "20261231"}