losartan potassium and hydrochlorothiazide (42291-503)

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide

Generic Name losartan potassium and hydrochlorothiazide

Labeler avkare

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, losartan potassium 100 mg/1

Manufacturer

AvKARE

Identifiers & Regulatory

Product NDC 42291-503

Product ID 42291-503_3d743217-99d1-2bbc-e063-6294a90a6adf

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201845

Listing Expiration 2026-12-31

Marketing Start 2022-08-31

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 42291503

Hyphenated Format 42291-503

Supplemental Identifiers

RxCUI

979464 979468 979471

UNII

0J48LPH2TH 3ST302B24A

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 losartan potassium and hydrochlorothiazide (source: ndc)

Generic Name losartan potassium and hydrochlorothiazide (source: ndc)

Application Number ANDA201845 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
100 mg/1

source: ndc

Packaging

1000 TABLET, FILM COATED in 1 BOTTLE (42291-503-10)
90 TABLET, FILM COATED in 1 BOTTLE (42291-503-90)

source: ndc

Packages (2)

42291-503-10 1000 TABLET, FILM COATED in 1 BOTTLE (42291-503-10) 42291-503-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-503-90)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) losartan potassium (100 mg/1)

Linked Drug Pages (1)

Losartan Potassium and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3d743217-99d1-2bbc-e063-6294a90a6adf", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464", "979468", "979471"], "spl_set_id": ["e78b2195-a2da-3d03-e053-2a95a90a7d56"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42291-503-10)", "package_ndc": "42291-503-10", "marketing_start_date": "20250121"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42291-503-90)", "package_ndc": "42291-503-90", "marketing_start_date": "20220831"}], "brand_name": "Losartan Potassium and Hydrochlorothiazide", "product_id": "42291-503_3d743217-99d1-2bbc-e063-6294a90a6adf", "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": "42291-503", "generic_name": "losartan potassium and hydrochlorothiazide", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Losartan Potassium and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "LOSARTAN POTASSIUM", "strength": "100 mg/1"}], "application_number": "ANDA201845", "marketing_category": "ANDA", "marketing_start_date": "20220831", "listing_expiration_date": "20261231"}