losartan potassium and hydrochlorothiazide (43547-425)

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide

Generic Name losartan potassium and hydrochlorothiazide

Labeler solco healthcare us, llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-425

Product ID 43547-425_0be72eb2-c56a-4721-8cb5-d9b778c3e179

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204901

Listing Expiration 2027-12-31

Marketing Start 2018-02-15

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 43547425

Hyphenated Format 43547-425

Supplemental Identifiers

RxCUI

979464 979468 979471

UPC

0343547424091 0343547425098 0343547423094

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 losartan potassium and hydrochlorothiazide (source: ndc)

Generic Name losartan potassium and hydrochlorothiazide (source: ndc)

Application Number ANDA204901 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
100 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (43547-425-03)
90 TABLET, FILM COATED in 1 BOTTLE (43547-425-09)
1000 TABLET, FILM COATED in 1 BOTTLE (43547-425-11)

source: ndc

Packages (3)

43547-425-03 30 TABLET, FILM COATED in 1 BOTTLE (43547-425-03) 43547-425-09 90 TABLET, FILM COATED in 1 BOTTLE (43547-425-09) 43547-425-11 1000 TABLET, FILM COATED in 1 BOTTLE (43547-425-11)

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": "0be72eb2-c56a-4721-8cb5-d9b778c3e179", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0343547424091", "0343547425098", "0343547423094"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464", "979468", "979471"], "spl_set_id": ["6d677f9e-c0e4-4d6e-bea2-a58e986e4635"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43547-425-03)", "package_ndc": "43547-425-03", "marketing_start_date": "20180215"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (43547-425-09)", "package_ndc": "43547-425-09", "marketing_start_date": "20180215"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (43547-425-11)", "package_ndc": "43547-425-11", "marketing_start_date": "20180215"}], "brand_name": "Losartan Potassium and Hydrochlorothiazide", "product_id": "43547-425_0be72eb2-c56a-4721-8cb5-d9b778c3e179", "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": "43547-425", "generic_name": "losartan potassium and hydrochlorothiazide", "labeler_name": "Solco Healthcare US, LLC", "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": "ANDA204901", "marketing_category": "ANDA", "marketing_start_date": "20180215", "listing_expiration_date": "20271231"}