losartan potassium and hydrochlorothiazide (72189-327)

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide

Generic Name losartan potassium and hydrochlorothiazide

Labeler direct rx

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Direct Rx

Identifiers & Regulatory

Product NDC 72189-327

Product ID 72189-327_4c4c415b-609e-7934-e063-6394a90a63ba

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204901

Listing Expiration 2027-12-31

Marketing Start 2022-02-17

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 72189327

Hyphenated Format 72189-327

Supplemental Identifiers

RxCUI

979464

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 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 (72189-327-30)
90 TABLET, FILM COATED in 1 BOTTLE (72189-327-90)

source: ndc

Packages (2)

72189-327-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-327-30) 72189-327-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-327-90)

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": "4c4c415b-609e-7934-e063-6394a90a63ba", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464"], "spl_set_id": ["d838e918-2463-79f6-e053-2a95a90a948d"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Direct Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-327-30)", "package_ndc": "72189-327-30", "marketing_start_date": "20220217"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-327-90)", "package_ndc": "72189-327-90", "marketing_start_date": "20220217"}], "brand_name": "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE", "product_id": "72189-327_4c4c415b-609e-7934-e063-6394a90a63ba", "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": "72189-327", "generic_name": "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE", "labeler_name": "Direct Rx", "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": "20220217", "listing_expiration_date": "20271231"}