losartan potassium and hydrochlorothiazide (29300-191)

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide

Generic Name losartan potassium and hydrochlorothiazide

Labeler unichem pharmaceuticals (usa), inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-191

Product ID 29300-191_ad6e4664-08b6-4480-a1fb-6663c8024fef

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204832

Listing Expiration 2026-12-31

Marketing Start 2017-07-21

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 29300191

Hyphenated Format 29300-191

Supplemental Identifiers

RxCUI

979464 979468 979471

UPC

0329300190137 0329300191134 0329300192131

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 ANDA204832 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
100 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-01)
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-10)
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-13)
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-19)

source: ndc

Packages (4)

29300-191-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-01) 29300-191-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-10) 29300-191-13 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-13) 29300-191-19 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-19)

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": "ad6e4664-08b6-4480-a1fb-6663c8024fef", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0329300190137", "0329300191134", "0329300192131"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464", "979468", "979471"], "spl_set_id": ["f61b4ffe-cca6-482d-88fa-adf22cb3fff2"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-01)", "package_ndc": "29300-191-01", "marketing_start_date": "20180115"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-10)", "package_ndc": "29300-191-10", "marketing_start_date": "20180115"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-13)", "package_ndc": "29300-191-13", "marketing_start_date": "20180115"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-191-19)", "package_ndc": "29300-191-19", "marketing_start_date": "20180115"}], "brand_name": "losartan potassium and hydrochlorothiazide", "product_id": "29300-191_ad6e4664-08b6-4480-a1fb-6663c8024fef", "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": "29300-191", "generic_name": "losartan potassium and hydrochlorothiazide", "labeler_name": "Unichem Pharmaceuticals (USA), 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": "100 mg/1"}], "application_number": "ANDA204832", "marketing_category": "ANDA", "marketing_start_date": "20170721", "listing_expiration_date": "20261231"}