losartan potassium and hydrochlorothiazide

Generic: losartan potassium and hydrochlorothiazide

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name losartan potassium and hydrochlorothiazide
Generic Name losartan potassium and hydrochlorothiazide
Labeler quality care products, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-086
Product ID 83008-086_b2463971-2003-4f2a-9e1b-fb50c3dd8eaa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204901
Marketing Start 2024-08-28
Marketing End 2027-03-21

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 83008086
Hyphenated Format 83008-086

Supplemental Identifiers

RxCUI
979471
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
  • 25 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (83008-086-90)
source: ndc

Packages (1)

83008-086-90 90 TABLET, FILM COATED in 1 BOTTLE (83008-086-90)

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": "b2463971-2003-4f2a-9e1b-fb50c3dd8eaa", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979471"], "spl_set_id": ["a6241e63-1952-4dfa-ba94-c406059501dd"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (83008-086-90)", "package_ndc": "83008-086-90", "marketing_end_date": "20270321", "marketing_start_date": "20240828"}], "brand_name": "Losartan Potassium and Hydrochlorothiazide", "product_id": "83008-086_b2463971-2003-4f2a-9e1b-fb50c3dd8eaa", "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": "83008-086", "generic_name": "losartan potassium and hydrochlorothiazide", "labeler_name": "Quality Care Products, 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": "ANDA204901", "marketing_category": "ANDA", "marketing_end_date": "20270321", "marketing_start_date": "20240828"}