losartan potassium and hydrochlorothiazide

Generic: losartan potassium and hydrochlorothiazide

Labeler: macleods pharmaceuticals 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 macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-052
Product ID 33342-052_cf31d31e-9355-47da-9c2b-8e4b84ac8159
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202289
Listing Expiration 2026-12-31
Marketing Start 2012-05-03

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 33342052
Hyphenated Format 33342-052

Supplemental Identifiers

RxCUI
979464 979468 979471
UPC
0333342051448 0333342050106 0333342052100 0333342051103 0333342052445 0333342051073 0333342052070
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 ANDA202289 (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 (33342-052-07)
  • 90 TABLET, FILM COATED in 1 BOTTLE (33342-052-10)
  • 10 BLISTER PACK in 1 CARTON (33342-052-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1000 TABLET, FILM COATED in 1 BOTTLE (33342-052-44)
source: ndc

Packages (4)

33342-052-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-052-07) 33342-052-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-052-10) 33342-052-12 10 BLISTER PACK in 1 CARTON (33342-052-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 33342-052-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-052-44)

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": "cf31d31e-9355-47da-9c2b-8e4b84ac8159", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0333342051448", "0333342050106", "0333342052100", "0333342051103", "0333342052445", "0333342051073", "0333342052070"], "unii": ["0J48LPH2TH", "3ST302B24A"], "rxcui": ["979464", "979468", "979471"], "spl_set_id": ["a04b5622-2c49-4d61-92b1-5dc523af7a24"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-052-07)", "package_ndc": "33342-052-07", "marketing_start_date": "20120910"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-052-10)", "package_ndc": "33342-052-10", "marketing_start_date": "20120910"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-052-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-052-12", "marketing_start_date": "20120910"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-052-44)", "package_ndc": "33342-052-44", "marketing_start_date": "20120910"}], "brand_name": "Losartan potassium and Hydrochlorothiazide", "product_id": "33342-052_cf31d31e-9355-47da-9c2b-8e4b84ac8159", "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": "33342-052", "generic_name": "Losartan potassium and Hydrochlorothiazide", "labeler_name": "Macleods Pharmaceuticals Limited", "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": "ANDA202289", "marketing_category": "ANDA", "marketing_start_date": "20120503", "listing_expiration_date": "20261231"}