bisoprolol fumarate and hydrochlorothiazide

Generic: bisoprolol fumarate and hydrochlorothiazide

Labeler: zydus lifesciences limited
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 zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bisoprolol fumarate 10 mg/1, hydrochlorothiazide 6.25 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1762
Product ID 70771-1762_9d6e36f0-a9e4-4b66-997a-fd5f8e4e1cf7
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 707711762
Hyphenated Format 70771-1762

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
  • 10 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (70771-1762-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (70771-1762-3)
  • 500 TABLET, FILM COATED in 1 BOTTLE (70771-1762-5)
source: ndc

Packages (3)

Ingredients (2)

bisoprolol fumarate (10 mg/1) hydrochlorothiazide (6.25 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "9d6e36f0-a9e4-4b66-997a-fd5f8e4e1cf7", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "UR59KN573L"], "rxcui": ["854908", "854916", "854919"], "spl_set_id": ["35ed3030-a9b3-4e4e-99cd-6d5c31ad22fa"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70771-1762-1)", "package_ndc": "70771-1762-1", "marketing_start_date": "20230301"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70771-1762-3)", "package_ndc": "70771-1762-3", "marketing_start_date": "20230301"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70771-1762-5)", "package_ndc": "70771-1762-5", "marketing_start_date": "20230301"}], "brand_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "product_id": "70771-1762_9d6e36f0-a9e4-4b66-997a-fd5f8e4e1cf7", "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": "70771-1762", "generic_name": "bisoprolol fumarate and hydrochlorothiazide", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bisoprolol Fumarate and Hydrochlorothiazide", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "10 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "6.25 mg/1"}], "application_number": "ANDA215666", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}