Is Hydrochlorothiazide + Losartan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Hydrochlorothiazide + Losartan, including AZAR-D 100/25 mg film-coated tablet (50,12.5 mg,mg, Film-coated tablet, SAR 48.20); AZAR-D 50/12.5 mg film-coated tablet (50,12.5 mg,mg, Film-coated tablet, SAR 41.90); FORTZAAR 100/25 mg film-coated tablet (100,25 mg,mg, Film-coated tablet, SAR 45.00); HYZAAR 50/12.5 mg film-coated tablet (50,12.5 mg,mg, Film-coated tablet, SAR 39.10); SORTIVA H 100-25MG F.C. TABLETS (100,25 mg,mg, Film-coated tablet, SAR 48.20).

Is Hydrochlorothiazide + Losartan approved by the US FDA?

Drugs@FDA lists 19 application product lines for Hydrochlorothiazide + Losartan, including HYZAAR (Prescription); LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (Prescription); LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (Prescription); LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (Prescription); LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (Prescription).

Active substances

Hydrochlorothiazide + Losartan

SFDA 8
US FDA 19
Health Canada 21
US price lines 6
NHS prices 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AZAR-D 100/25 mg film-coated tablet	50,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 48.20	Generic · Prescription	COOPER PHARMA	Valid
AZAR-D 50/12.5 mg film-coated tablet	50,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 41.90	Generic · Prescription	Cooper Pharma Arabia	Valid
FORTZAAR 100/25 mg film-coated tablet	100,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 45.00	Generic · Prescription	N.V. Organon	Valid
HYZAAR 50/12.5 mg film-coated tablet	50,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 39.10	NCE · Prescription	ORGANON	Valid
SORTIVA H 100-25MG F.C. TABLETS	100,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 48.20	Generic · Prescription	SPIMACO ADDWAEIH	Valid
SORTIVA H 100/12.5 mg film-coated tablet	100,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 48.20	Generic · Prescription	SPIMACO ADDWAEIH	Valid
SORTIVA H 50-12.5MG F.C. TABLETS	50,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 41.90	Generic · Prescription	SPIMACO ADDWAEIH	Valid
HYZAAR	100,12.5 mg,mg	Tablet · Oral use	28 Blister	SAR 80.10	Generic · Prescription	MERCK SHARP & DOHME	Invalid · Not Marketed

Indications — CHI Daman Drug Formulary

HYPERTENSION

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
HYZAAR	12.5MG;50MG; 25MG;100MG; 12.5MG;100MG	tablet · oral	ORGANON	Prescription	28 Apr 1995
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	TEVA PHARMS	Prescription	6 Apr 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	LUPIN LTD	Prescription	21 May 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 25MG;100MG; 12.5MG;100MG	tablet · oral	CHARTWELL RX	Prescription	19 Aug 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 25MG;100MG	tablet · oral	ZYDUS PHARMS USA INC	Prescription	6 Oct 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	AUROBINDO PHARMA	Prescription	6 Oct 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	ALEMBIC PHARMS LTD	Prescription	17 Feb 2012
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	MACLEODS PHARMS LTD	Prescription	9 Aug 2012
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	JUBILANT CADISTA	Prescription	18 Sep 2012
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	UNICHEM	Prescription	21 Jul 2017
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	PRINSTON INC	Prescription	6 Nov 2017
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	HETERO LABS LTD V	Prescription	27 May 2026
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG; 12.5MG;50MG; 25MG;100MG	tablet · oral	HIKMA PHARMS	Discontinued	6 Apr 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 25MG;100MG; 12.5MG;100MG	tablet · oral	TORRENT PHARMS	Discontinued	6 Apr 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	MYLAN	Discontinued	6 Apr 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	APOTEX	Discontinued	11 Aug 2010
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	WATSON LABS	Discontinued	12 Jan 2011
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	IPCA LABS LTD	Discontinued	1 Mar 2013
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG; 12.5MG;100MG; 25MG;100MG	tablet · oral	GRANULES	Discontinued	29 Sep 2023

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-LOSARTAN HCT	02423642	50 MG; 12.5 MG	TABLET · ORAL	AURO PHARMA INC
AURO-LOSARTAN HCT	02423650	12.5 MG; 100 MG	TABLET · ORAL	AURO PHARMA INC
AURO-LOSARTAN HCT	02423669	100 MG; 25 MG	TABLET · ORAL	AURO PHARMA INC
HYZAAR	02230047	50 MG; 12.5 MG	TABLET · ORAL	ORGANON CANADA INC.
HYZAAR	02297841	100 MG; 12.5 MG	TABLET · ORAL	ORGANON CANADA INC.
HYZAAR DS	02241007	100 MG; 25 MG	TABLET · ORAL	ORGANON CANADA INC.
LOSARTAN HCT	02388960	12.5 MG; 50 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
LOSARTAN HCT	02388979	12.5 MG; 100 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
LOSARTAN HCT DS	02388987	100 MG; 25 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
LOSARTAN/HCTZ	02427648	50 MG; 12.5 MG	TABLET · ORAL	SANIS HEALTH INC
LOSARTAN/HCTZ	02427656	100 MG; 12.5 MG	TABLET · ORAL	SANIS HEALTH INC
LOSARTAN/HCTZ	02427664	100 MG; 25 MG	TABLET · ORAL	SANIS HEALTH INC
MINT-LOSARTAN/HCTZ	02389657	50 MG; 12.5 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-LOSARTAN/HCTZ	02389665	12.5 MG; 100 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-LOSARTAN/HCTZ DS	02389673	100.0 MG; 25.0 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
PMS-LOSARTAN-HCTZ	02392224	12.5 MG; 50 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-LOSARTAN-HCTZ	02392232	100 MG; 12.5 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-LOSARTAN-HCTZ	02392240	100 MG; 25 MG	TABLET · ORAL	PHARMASCIENCE INC
SANDOZ LOSARTAN HCT	02313375	50 MG; 12.5 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ LOSARTAN HCT	02362449	12.5 MG; 100 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ LOSARTAN HCT DS	02313383	25 MG; 100 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	HYZAAR 100-12.5 TABLET	$6.81999	per EA	1 Jan 2026
US NADAC	HYZAAR 100-25 TABLET	$6.7968	per EA	23 Sep 2026
US NADAC	HYZAAR 50-12.5 TABLET	$5.00845	per EA	1 Jan 2026
US NADAC	LOSARTAN-HYDROCHLOROTHIAZIDE 100-12.5 MG TAB	$0.07619	per EA	23 Sep 2026
US NADAC	LOSARTAN-HYDROCHLOROTHIAZIDE 100-25 MG TAB	$0.07925	per EA	23 Sep 2026
US NADAC	LOSARTAN-HYDROCHLOROTHIAZIDE 50-12.5 MG TAB	$0.05542	per EA	23 Sep 2026
NHS Drug Tariff	Losartan 100mg / Hydrochlorothiazide 12.5mg tablets	£1.81	28 tablet	1 Oct 2026
NHS Drug Tariff	Losartan 100mg / Hydrochlorothiazide 25mg tablets	£1.74	28 tablet	1 Oct 2026
NHS Drug Tariff	Losartan 50mg / Hydrochlorothiazide 12.5mg tablets	£1.41	28 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.