losartan potassium and hydrochlorothiazide (43063-986)

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide

Generic Name losartan potassium and hydrochlorothiazide

Labeler pd-rx pharmaceuticals, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-986

Product ID 43063-986_3fa43a1c-67b7-16b0-e063-6394a90ab672

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA091629

Listing Expiration 2026-12-31

Marketing Start 2010-10-06

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 43063986

Hyphenated Format 43063-986

Supplemental Identifiers

RxCUI

979468

UPC

0343063986301

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 BOTTLE, PLASTIC (43063-986-30)

source: ndc

Packages (1)

43063-986-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-986-30)

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": "3fa43a1c-67b7-16b0-e063-6394a90ab672", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0343063986301"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979468"], "spl_set_id": ["dcb39c6b-430d-4b3d-ba6f-5bf1efe116aa"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-986-30)", "package_ndc": "43063-986-30", "marketing_start_date": "20120831"}], "brand_name": "Losartan Potassium and Hydrochlorothiazide", "product_id": "43063-986_3fa43a1c-67b7-16b0-e063-6394a90ab672", "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": "43063-986", "generic_name": "Losartan Potassium and Hydrochlorothiazide", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20101006", "listing_expiration_date": "20261231"}