bisoprolol fumarate and hydrochlorothiazide

Generic: bisoprolol fumarate and hydrochlorothiazide

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bisoprolol fumarate and hydrochlorothiazide
Generic Name bisoprolol fumarate and hydrochlorothiazide
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2589
Product ID 71335-2589_f8af595c-3cbc-4e89-b7c8-1ab33290711a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215995
Listing Expiration 2026-12-31
Marketing Start 2022-01-26

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 713352589
Hyphenated Format 71335-2589

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 ANDA215995 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-2589-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-2589-2)
  • 28 TABLET, FILM COATED in 1 BOTTLE (71335-2589-3)
  • 100 TABLET, FILM COATED in 1 BOTTLE (71335-2589-4)
source: ndc

Packages (4)

71335-2589-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-2589-1) 71335-2589-2 90 TABLET, FILM COATED in 1 BOTTLE (71335-2589-2) 71335-2589-3 28 TABLET, FILM COATED in 1 BOTTLE (71335-2589-3) 71335-2589-4 100 TABLET, FILM COATED in 1 BOTTLE (71335-2589-4)

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": "f8af595c-3cbc-4e89-b7c8-1ab33290711a", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["UR59KN573L", "0J48LPH2TH"], "rxcui": ["854919"], "spl_set_id": ["794d4a5a-de31-4878-95d5-23552dd2171e"], "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, FILM COATED in 1 BOTTLE (71335-2589-1)", "package_ndc": "71335-2589-1", "marketing_start_date": "20250604"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-2589-2)", "package_ndc": "71335-2589-2", "marketing_start_date": "20250604"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (71335-2589-3)", "package_ndc": "71335-2589-3", "marketing_start_date": "20250604"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71335-2589-4)", "package_ndc": "71335-2589-4", "marketing_start_date": "20250604"}], "brand_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "product_id": "71335-2589_f8af595c-3cbc-4e89-b7c8-1ab33290711a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "71335-2589", "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": "ANDA215995", "marketing_category": "ANDA", "marketing_start_date": "20220126", "listing_expiration_date": "20261231"}