hyzaar

Generic: losartan potassium and hydrochlorothiazide

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name hyzaar
Generic Name losartan potassium and hydrochlorothiazide
Labeler organon llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydrochlorothiazide 25 mg/1, losartan potassium 100 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-141
Product ID 78206-141_10ae5107-90f4-4e30-9320-da164ad71bb7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020387
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

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 78206141
Hyphenated Format 78206-141

Supplemental Identifiers

RxCUI
979464 979466 979468 979470 979471 979473
UPC
0378206140012 0378206139016 0378206141019
UNII
0J48LPH2TH 3ST302B24A
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 hyzaar (source: ndc)
Generic Name losartan potassium and hydrochlorothiazide (source: ndc)
Application Number NDA020387 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (78206-141-01)
  • 90 TABLET, FILM COATED in 1 BOTTLE (78206-141-02)
source: ndc

Packages (2)

78206-141-01 30 TABLET, FILM COATED in 1 BOTTLE (78206-141-01) 78206-141-02 90 TABLET, FILM COATED in 1 BOTTLE (78206-141-02)

Ingredients (2)

hydrochlorothiazide (25 mg/1) losartan potassium (100 mg/1)

Linked Drug Pages (1)

HYZAAR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "10ae5107-90f4-4e30-9320-da164ad71bb7", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0378206140012", "0378206139016", "0378206141019"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464", "979466", "979468", "979470", "979471", "979473"], "spl_set_id": ["4116ccde-2e23-45f4-b12f-6337df877744"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (78206-141-01)", "package_ndc": "78206-141-01", "marketing_start_date": "20210601"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (78206-141-02)", "package_ndc": "78206-141-02", "marketing_start_date": "20210601"}], "brand_name": "HYZAAR", "product_id": "78206-141_10ae5107-90f4-4e30-9320-da164ad71bb7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "78206-141", "generic_name": "losartan potassium and hydrochlorothiazide", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYZAAR", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "LOSARTAN POTASSIUM", "strength": "100 mg/1"}], "application_number": "NDA020387", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}