losartan potassium and hydrochlorothiazide

Generic: losartan potassium and hydrochlorothiazide

Labeler: aurobindo pharma limited
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 aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-469
Product ID 65862-469_194eea48-8bc8-476d-a604-4b656222d5be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091629
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 65862469
Hyphenated Format 65862-469

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
  • 12.5 mg/1
  • 100 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (65862-469-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-469-30)
  • 5000 TABLET, FILM COATED in 1 BOTTLE (65862-469-59)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-469-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-469-99)
source: ndc

Packages (5)

65862-469-10 10 BLISTER PACK in 1 CARTON (65862-469-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-469-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-469-30) 65862-469-59 5000 TABLET, FILM COATED in 1 BOTTLE (65862-469-59) 65862-469-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-469-90) 65862-469-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-469-99)

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": "194eea48-8bc8-476d-a604-4b656222d5be", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464", "979468", "979471"], "spl_set_id": ["dc177d6c-c754-4379-8c2f-1cf6f52f950a"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-469-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-469-10", "marketing_start_date": "20101006"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-469-30)", "package_ndc": "65862-469-30", "marketing_start_date": "20101006"}, {"sample": false, "description": "5000 TABLET, FILM COATED in 1 BOTTLE (65862-469-59)", "package_ndc": "65862-469-59", "marketing_start_date": "20101006"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-469-90)", "package_ndc": "65862-469-90", "marketing_start_date": "20101006"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-469-99)", "package_ndc": "65862-469-99", "marketing_start_date": "20101006"}], "brand_name": "Losartan Potassium and Hydrochlorothiazide", "product_id": "65862-469_194eea48-8bc8-476d-a604-4b656222d5be", "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": "65862-469", "generic_name": "Losartan Potassium and Hydrochlorothiazide", "labeler_name": "Aurobindo Pharma Limited", "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": "ANDA091629", "marketing_category": "ANDA", "marketing_start_date": "20101006", "listing_expiration_date": "20261231"}