bisoprolol fumarate and hydrochlorothiazide (50090-6413)

Drug Facts

Product Profile

Brand Name bisoprolol fumarate and hydrochlorothiazide

Generic Name bisoprolol fumarate and hydrochlorothiazide

Labeler a-s medication solutions

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6413

Product ID 50090-6413_b4dbad3e-db70-448f-8946-c9a2ae7bec87

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA215562

Listing Expiration 2027-12-31

Marketing Start 2021-11-04

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 500906413

Hyphenated Format 50090-6413

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 ANDA215562 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
6.25 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (50090-6413-0)
90 TABLET in 1 BOTTLE (50090-6413-2)

source: ndc

Packages (2)

50090-6413-0 30 TABLET in 1 BOTTLE (50090-6413-0) 50090-6413-2 90 TABLET in 1 BOTTLE (50090-6413-2)

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": "b4dbad3e-db70-448f-8946-c9a2ae7bec87", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["UR59KN573L", "0J48LPH2TH"], "rxcui": ["854919"], "spl_set_id": ["90bb2207-2eaf-495b-a222-c69d4db9e7a3"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-6413-0)", "package_ndc": "50090-6413-0", "marketing_start_date": "20230328"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-6413-2)", "package_ndc": "50090-6413-2", "marketing_start_date": "20230328"}], "brand_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "product_id": "50090-6413_b4dbad3e-db70-448f-8946-c9a2ae7bec87", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "50090-6413", "generic_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "labeler_name": "A-S Medication Solutions", "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": "ANDA215562", "marketing_category": "ANDA", "marketing_start_date": "20211104", "listing_expiration_date": "20271231"}