bisoprolol fumarate and hydrochlorothiazide (72578-113)

Drug Facts

Product Profile

Brand Name bisoprolol fumarate and hydrochlorothiazide

Generic Name bisoprolol fumarate and hydrochlorothiazide

Labeler viona pharmaceuticals inc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

bisoprolol fumarate 2.5 mg/1, hydrochlorothiazide 6.25 mg/1

Manufacturer

Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-113

Product ID 72578-113_550e6ac5-3ece-461f-a9c5-2e4050a5eabb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA215666

Listing Expiration 2026-12-31

Marketing Start 2023-03-01

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 72578113

Hyphenated Format 72578-113

Supplemental Identifiers

RxCUI

854908 854916 854919

UNII

0J48LPH2TH UR59KN573L

NUI

N0000175359 N0000175419 M0471776

Packaging Origin

Original Packager

true

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 ANDA215666 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2.5 mg/1
6.25 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (72578-113-01)
500 TABLET, FILM COATED in 1 BOTTLE (72578-113-05)
30 TABLET, FILM COATED in 1 BOTTLE (72578-113-06)

source: ndc

Packages (3)

72578-113-01 100 TABLET, FILM COATED in 1 BOTTLE (72578-113-01) 72578-113-05 500 TABLET, FILM COATED in 1 BOTTLE (72578-113-05) 72578-113-06 30 TABLET, FILM COATED in 1 BOTTLE (72578-113-06)

Ingredients (2)

bisoprolol fumarate (2.5 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": "550e6ac5-3ece-461f-a9c5-2e4050a5eabb", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "UR59KN573L"], "rxcui": ["854908", "854916", "854919"], "spl_set_id": ["57505d73-f2a8-430b-8703-a0a6bb733c7d"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72578-113-01)", "package_ndc": "72578-113-01", "marketing_start_date": "20230301"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72578-113-05)", "package_ndc": "72578-113-05", "marketing_start_date": "20230301"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72578-113-06)", "package_ndc": "72578-113-06", "marketing_start_date": "20230301"}], "brand_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "product_id": "72578-113_550e6ac5-3ece-461f-a9c5-2e4050a5eabb", "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": "72578-113", "generic_name": "bisoprolol fumarate and hydrochlorothiazide", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bisoprolol Fumarate and Hydrochlorothiazide", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "2.5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "6.25 mg/1"}], "application_number": "ANDA215666", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}