bisoprolol fumarate and hydrochlorothiazide

Generic: bisoprolol fumarate and hydrochlorothiazide

Labeler: marlex pharmaceuticals, 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 marlex pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-741
Product ID 10135-741_3f7bca13-71ae-c3ed-e063-6294a90ac734
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215562
Listing Expiration 2026-12-31
Marketing Start 2022-05-01

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 10135741
Hyphenated Format 10135-741

Supplemental Identifiers

RxCUI
854908 854916 854919
UNII
0J48LPH2TH UR59KN573L
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
  • 100 TABLET in 1 BOTTLE (10135-741-01)
  • 500 TABLET in 1 BOTTLE (10135-741-05)
source: ndc

Packages (2)

10135-741-01 100 TABLET in 1 BOTTLE (10135-741-01) 10135-741-05 500 TABLET in 1 BOTTLE (10135-741-05)

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": "3f7bca13-71ae-c3ed-e063-6294a90ac734", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "UR59KN573L"], "rxcui": ["854908", "854916", "854919"], "spl_set_id": ["df881501-42ae-624a-e053-2995a90ab2a0"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10135-741-01)", "package_ndc": "10135-741-01", "marketing_start_date": "20220501"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (10135-741-05)", "package_ndc": "10135-741-05", "marketing_start_date": "20220501"}], "brand_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "product_id": "10135-741_3f7bca13-71ae-c3ed-e063-6294a90ac734", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "10135-741", "generic_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "labeler_name": "Marlex 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": "ANDA215562", "marketing_category": "ANDA", "marketing_start_date": "20220501", "listing_expiration_date": "20261231"}