losartan potassium and hydrochlorothiazide (67046-1618)

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide

Generic Name losartan potassium and hydrochlorothiazide

Labeler coupler llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, losartan potassium 50 mg/1

Manufacturer

Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1618

Product ID 67046-1618_48c0d7d3-b63e-047e-e063-6394a90a0518

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA091629

Listing Expiration 2027-12-31

Marketing Start 2025-12-02

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 670461618

Hyphenated Format 67046-1618

Supplemental Identifiers

RxCUI

979468

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 ANDA091629 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
50 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1618-3)

source: ndc

Packages (1)

67046-1618-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1618-3)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) losartan potassium (50 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": "48c0d7d3-b63e-047e-e063-6394a90a0518", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979468"], "spl_set_id": ["44fd38d2-cb8b-d0e8-e063-6294a90a994e"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1618-3)", "package_ndc": "67046-1618-3", "marketing_start_date": "20251202"}], "brand_name": "Losartan Potassium and Hydrochlorothiazide", "product_id": "67046-1618_48c0d7d3-b63e-047e-e063-6394a90a0518", "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": "67046-1618", "generic_name": "Losartan Potassium and Hydrochlorothiazide", "labeler_name": "Coupler 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": "50 mg/1"}], "application_number": "ANDA091629", "marketing_category": "ANDA", "marketing_start_date": "20251202", "listing_expiration_date": "20271231"}