losartan potassium and hydrochlorothiazide (16714-225)

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide

Generic Name losartan potassium and hydrochlorothiazide

Labeler northstar rx llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, losartan potassium 100 mg/1

Manufacturer

NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-225

Product ID 16714-225_d3aeeeca-2c3a-4006-89f7-e3836aa8399b

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA091629

Listing Expiration 2026-12-31

Marketing Start 2024-09-04

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 16714225

Hyphenated Format 16714-225

Supplemental Identifiers

RxCUI

979464 979468 979471

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 ANDA091629 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
100 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (16714-225-01)
90 TABLET, FILM COATED in 1 BOTTLE (16714-225-02)
1000 TABLET, FILM COATED in 1 BOTTLE (16714-225-04)

source: ndc

Packages (3)

16714-225-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-225-01) 16714-225-02 90 TABLET, FILM COATED in 1 BOTTLE (16714-225-02) 16714-225-04 1000 TABLET, FILM COATED in 1 BOTTLE (16714-225-04)

Ingredients (2)

hydrochlorothiazide (25 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": "d3aeeeca-2c3a-4006-89f7-e3836aa8399b", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464", "979468", "979471"], "spl_set_id": ["25318baf-9c2f-458f-b9ea-f52dabca49af"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16714-225-01)", "package_ndc": "16714-225-01", "marketing_start_date": "20240904"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16714-225-02)", "package_ndc": "16714-225-02", "marketing_start_date": "20240904"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16714-225-04)", "package_ndc": "16714-225-04", "marketing_start_date": "20240904"}], "brand_name": "Losartan Potassium and Hydrochlorothiazide", "product_id": "16714-225_d3aeeeca-2c3a-4006-89f7-e3836aa8399b", "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": "16714-225", "generic_name": "Losartan Potassium and Hydrochlorothiazide", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Losartan Potassium and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "LOSARTAN POTASSIUM", "strength": "100 mg/1"}], "application_number": "ANDA091629", "marketing_category": "ANDA", "marketing_start_date": "20240904", "listing_expiration_date": "20261231"}