losartan potassium and hydrochlorothiazide (68180-215)

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide

Generic Name losartan potassium and hydrochlorothiazide

Labeler lupin pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-215

Product ID 68180-215_6b0e9bc3-30a9-47ce-8cbe-c51404d51ae6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078245

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 68180215

Hyphenated Format 68180-215

Supplemental Identifiers

RxCUI

979464 979468 979471

UPC

0368180215066 0368180217060

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 ANDA078245 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
50 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (68180-215-06)
90 TABLET in 1 BOTTLE (68180-215-09)

source: ndc

Packages (2)

68180-215-06 30 TABLET in 1 BOTTLE (68180-215-06) 68180-215-09 90 TABLET in 1 BOTTLE (68180-215-09)

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": "6b0e9bc3-30a9-47ce-8cbe-c51404d51ae6", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0368180215066", "0368180217060"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464", "979468", "979471"], "spl_set_id": ["ee1eaaf6-050b-48af-942b-5e3451edc164"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68180-215-06)", "package_ndc": "68180-215-06", "marketing_start_date": "20101006"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68180-215-09)", "package_ndc": "68180-215-09", "marketing_start_date": "20101006"}], "brand_name": "Losartan Potassium and Hydrochlorothiazide", "product_id": "68180-215_6b0e9bc3-30a9-47ce-8cbe-c51404d51ae6", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "68180-215", "generic_name": "Losartan Potassium and Hydrochlorothiazide", "labeler_name": "Lupin 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": "ANDA078245", "marketing_category": "ANDA", "marketing_start_date": "20101006", "listing_expiration_date": "20261231"}