bisoprolol fumarate and hydrochlorothiazide (0378-0503)

Drug Facts

Product Profile

Brand Name bisoprolol fumarate and hydrochlorothiazide

Generic Name bisoprolol fumarate and hydrochlorothiazide

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0503

Product ID 0378-0503_7668189e-e148-4a21-b990-44f9a668df5c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA075768

Listing Expiration 2026-12-31

Marketing Start 2021-02-22

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 03780503

Hyphenated Format 0378-0503

Supplemental Identifiers

RxCUI

854908 854916 854919

UPC

0303780505018 0303780503014 0303780501010

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 ANDA075768 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
6.25 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0503-01)

source: ndc

Packages (1)

0378-0503-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0503-01)

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": "7668189e-e148-4a21-b990-44f9a668df5c", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0303780505018", "0303780503014", "0303780501010"], "unii": ["0J48LPH2TH", "UR59KN573L"], "rxcui": ["854908", "854916", "854919"], "spl_set_id": ["d4243a76-516c-417e-80ba-444a21ecc688"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0503-01)", "package_ndc": "0378-0503-01", "marketing_start_date": "20210222"}], "brand_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "product_id": "0378-0503_7668189e-e148-4a21-b990-44f9a668df5c", "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": "0378-0503", "generic_name": "bisoprolol fumarate and hydrochlorothiazide", "labeler_name": "Mylan Pharmaceuticals Inc.", "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": "ANDA075768", "marketing_category": "ANDA", "marketing_start_date": "20210222", "listing_expiration_date": "20261231"}