Package 0378-0501-01

Brand: bisoprolol fumarate and hydrochlorothiazide

Generic: bisoprolol fumarate and hydrochlorothiazide
NDC Package

Package Facts

Identity

Package NDC 0378-0501-01
Digits Only 0378050101
Product NDC 0378-0501
Description

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0501-01)

Marketing

Marketing Status
Marketed Since 2021-02-22
Brand bisoprolol fumarate and hydrochlorothiazide
Generic bisoprolol fumarate and hydrochlorothiazide
Sample Package No

Linked Drug Pages (1)

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 (0378-0501-01)", "package_ndc": "0378-0501-01", "marketing_start_date": "20210222"}], "brand_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "product_id": "0378-0501_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": "0378-0501", "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": "2.5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "6.25 mg/1"}], "application_number": "ANDA075768", "marketing_category": "ANDA", "marketing_start_date": "20210222", "listing_expiration_date": "20261231"}