bisoprolol fumarate and hydrochlorothiazide

Generic: bisoprolol fumarate and hydrochlorothiazide

Labeler: edenbridge pharmaceuticals llc.
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 edenbridge pharmaceuticals llc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Edenbridge Pharmaceuticals LLC.

Identifiers & Regulatory

Product NDC 42799-921
Product ID 42799-921_46410e5f-f09f-62ff-e063-6394a90afdda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212678
Listing Expiration 2026-12-31
Marketing Start 2019-04-30

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 42799921
Hyphenated Format 42799-921

Supplemental Identifiers

RxCUI
854908 854916 854919
UPC
0342799922300 0342799921020 0342799921013 0342799921303 0342799920306 0342799922027 0342799920016 0342799920023
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 ANDA212678 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42799-921-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (42799-921-02)
  • 30 TABLET, FILM COATED in 1 BOTTLE (42799-921-30)
source: ndc

Packages (3)

42799-921-01 100 TABLET, FILM COATED in 1 BOTTLE (42799-921-01) 42799-921-02 500 TABLET, FILM COATED in 1 BOTTLE (42799-921-02) 42799-921-30 30 TABLET, FILM COATED in 1 BOTTLE (42799-921-30)

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": "46410e5f-f09f-62ff-e063-6394a90afdda", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0342799922300", "0342799921020", "0342799921013", "0342799921303", "0342799920306", "0342799922027", "0342799920016", "0342799920023"], "unii": ["0J48LPH2TH", "UR59KN573L"], "rxcui": ["854908", "854916", "854919"], "spl_set_id": ["295532b5-65c8-40c3-8d27-cfd334d12802"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Edenbridge Pharmaceuticals LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42799-921-01)", "package_ndc": "42799-921-01", "marketing_start_date": "20190430"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42799-921-02)", "package_ndc": "42799-921-02", "marketing_start_date": "20190430"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42799-921-30)", "package_ndc": "42799-921-30", "marketing_start_date": "20190430"}], "brand_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "product_id": "42799-921_46410e5f-f09f-62ff-e063-6394a90afdda", "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": "42799-921", "generic_name": "Bisoprolol Fumarate and Hydrochlorothiazide", "labeler_name": "Edenbridge Pharmaceuticals LLC.", "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": "ANDA212678", "marketing_category": "ANDA", "marketing_start_date": "20190430", "listing_expiration_date": "20261231"}