bisoprolol fumarate and hydrochlorothiazide

Generic: bisoprolol fumarate and hydrochlorothiazide

Labeler: unichem pharmaceuticals (usa), inc.
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 unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-189
Product ID 29300-189_057844aa-5d7e-4e83-b71f-9072d2a2b93d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079106
Listing Expiration 2026-12-31
Marketing Start 2010-10-12

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 29300189
Hyphenated Format 29300-189

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 ANDA079106 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (29300-189-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (29300-189-05)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (29300-189-10)
  • 30 TABLET in 1 BOTTLE, PLASTIC (29300-189-13)
source: ndc

Packages (4)

29300-189-01 100 TABLET in 1 BOTTLE, PLASTIC (29300-189-01) 29300-189-05 500 TABLET in 1 BOTTLE, PLASTIC (29300-189-05) 29300-189-10 1000 TABLET in 1 BOTTLE, PLASTIC (29300-189-10) 29300-189-13 30 TABLET in 1 BOTTLE, PLASTIC (29300-189-13)

Ingredients (2)

bisoprolol fumarate (10 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": "057844aa-5d7e-4e83-b71f-9072d2a2b93d", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "UR59KN573L"], "rxcui": ["854908", "854916", "854919"], "spl_set_id": ["b9ee689a-ea12-435d-b01c-70d45891e62f"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (29300-189-01)", "package_ndc": "29300-189-01", "marketing_start_date": "20101012"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (29300-189-05)", "package_ndc": "29300-189-05", "marketing_start_date": "20101012"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (29300-189-10)", "package_ndc": "29300-189-10", "marketing_start_date": "20101012"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (29300-189-13)", "package_ndc": "29300-189-13", "marketing_start_date": "20101012"}], "brand_name": "bisoprolol fumarate and hydrochlorothiazide", "product_id": "29300-189_057844aa-5d7e-4e83-b71f-9072d2a2b93d", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "29300-189", "generic_name": "bisoprolol fumarate and hydrochlorothiazide", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "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": "ANDA079106", "marketing_category": "ANDA", "marketing_start_date": "20101012", "listing_expiration_date": "20261231"}