Is Hydrochlorothiazide + Valsartan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 41 valid registrations of Hydrochlorothiazide + Valsartan, including ARBAVAL PLUS (160,12.5 mg,mg, Film-coated tablet, SAR 27.25); ARBAVAL PLUS (160,25 mg,mg, Film-coated tablet, SAR 27.25); ARBAVAL PLUS (320,25 mg,mg, Film-coated tablet, SAR 37.15); ARBITEN PLUS (80,12.5 mg,mg, Film-coated tablet, SAR 29.80); ARBITEN PLUS (160,25 mg,mg, Film-coated tablet, SAR 32.50).

Is Hydrochlorothiazide + Valsartan approved by the US FDA?

Drugs@FDA lists 12 application product lines for Hydrochlorothiazide + Valsartan, including DIOVAN HCT (Prescription); VALSARTAN AND HYDROCHLOROTHIAZIDE (Prescription); VALSARTAN AND HYDROCHLOROTHIAZIDE (Prescription); VALSARTAN AND HYDROCHLOROTHIAZIDE (Prescription); VALSARTAN AND HYDROCHLOROTHIAZIDE (Prescription).

Active substances

Hydrochlorothiazide + Valsartan

SFDA 49
US FDA 12
Health Canada 32
US price lines 8
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
ARBAVAL PLUS	160,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 27.25	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
ARBAVAL PLUS	160,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 27.25	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
ARBAVAL PLUS	320,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 37.15	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
ARBITEN PLUS	80,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 29.80	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
ARBITEN PLUS	160,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 32.50	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
ARBITEN PLUS	160,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 32.50	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
Avysk HCT	160,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 30.30	Generic · Prescription	Med City Pharma	Valid
Avysk HCT	160,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 30.30	Generic · Prescription	Med City Pharma	Valid
Avysk HCT	80,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 27.80	Generic · Prescription	Med City Pharma	Valid
CO-ANGINET	80,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 22.40	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
CO-ANGINET	160,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 24.50	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
CO-ANGINET	160,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 24.50	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
CO-CINFAVAL	160,12.5 mg,mg	Film-coated tablet · Oral use	28 Bottle	SAR 22.85	Generic · Prescription	LABORATORIOS CINFA SA	Valid
CO-CINFAVAL	160,25 mg,mg	Film-coated tablet · Oral use	28 Bottle	SAR 22.85	Generic · Prescription	LABORATORIOS CINFA SA	Valid
CO-CINFAVAL	80,12.5 mg,mg	Film-coated tablet · Oral use	28 Bottle	SAR 11.45	Generic · Prescription	LABORATORIOS CINFA SA	Valid
CO-DIOVAN	320,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 57.85	NCE · Prescription	NOVARTIS	Valid
CO-DIOVAN	320,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 57.85	NCE · Prescription	NOVARTIS	Valid
CO-DIOVAN	160,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 42.50	NCE · Prescription	NOVARTIS	Valid
CO-DIOVAN	160,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 42.50	NCE · Prescription	NOVARTIS	Valid
CO-DIOVAN	80,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 38.95	NCE · Prescription	NOVARTIS	Valid
CO-TABUVAN	80,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 33.10	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
CO-TABUVAN	320,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 49.15	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
CO-TABUVAN	320,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 49.15	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
CO-TABUVAN	160,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 36.10	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
CO-TABUVAN	160,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 36.10	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid

24 more — full table

Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE; HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
DIOVAN HCT	12.5MG;80MG; 12.5MG;160MG; 25MG;160MG; 12.5MG;320MG; 25MG;320MG	tablet · oral	NOVARTIS	Prescription	6 Mar 1998
VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG; 12.5MG;160MG; 25MG;160MG; 12.5MG;320MG; 25MG;320MG	tablet · oral	MYLAN PHARMS INC	Prescription	21 Sep 2012
VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG; 12.5MG;160MG; 12.5MG;320MG; 25MG;160MG; 25MG;320MG	tablet · oral	ALEMBIC	Prescription	21 Mar 2013
VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG; 12.5MG;160MG; 12.5MG;320MG; 25MG;160MG; 25MG;320MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	21 Mar 2013
VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG; 12.5MG;160MG; 12.5MG;320MG; 25MG;160MG; 25MG;320MG	tablet · oral	MACLEODS PHARMS LTD	Prescription	19 Apr 2013
VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG; 12.5MG;160MG; 12.5MG;320MG; 25MG;160MG; 25MG;320MG	tablet · oral	PRINSTON INC	Prescription	8 Feb 2016
VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG; 12.5MG;160MG; 25MG;160MG; 12.5MG;320MG; 25MG;320MG	tablet · oral	AMNEAL PHARMS	Prescription	11 Aug 2023
VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG; 12.5MG;160MG; 12.5MG;320MG; 25MG;160MG; 25MG;320MG	tablet · oral	SCIEGEN PHARMS	Prescription	23 Apr 2026
VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;320MG; 25MG;320MG; 12.5MG;80MG; 12.5MG;160MG; 25MG;160MG	tablet · oral	LUPIN LTD	Discontinued	21 Mar 2013
VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG; 12.5MG;160MG; 12.5MG;320MG; 25MG;160MG; 25MG;320MG	tablet · oral	WATSON LABS TEVA	Discontinued	21 Mar 2013
VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG; 12.5MG;160MG; 12.5MG;320MG; 25MG;160MG; 25MG;320MG	tablet · oral	APOTEX INC	Discontinued	21 Mar 2013
VALSARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG; 12.5MG;160MG; 12.5MG;320MG; 25MG;160MG; 25MG;320MG	tablet · oral	ZYDUS LIFESCIENCES	Discontinued	15 Mar 2019

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-VALSARTAN HCT	02408112	12.5 MG; 80 MG	TABLET · ORAL	AURO PHARMA INC
AURO-VALSARTAN HCT	02408120	160 MG; 12.5 MG	TABLET · ORAL	AURO PHARMA INC
AURO-VALSARTAN HCT	02408139	160 MG; 25 MG	TABLET · ORAL	AURO PHARMA INC
AURO-VALSARTAN HCT	02408147	320 MG; 12.5 MG	TABLET · ORAL	AURO PHARMA INC
AURO-VALSARTAN HCT	02408155	320 MG; 25 MG	TABLET · ORAL	AURO PHARMA INC
DIOVAN-HCT	02241900	12.5 MG; 80 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
DIOVAN-HCT	02241901	12.5 MG; 160 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
DIOVAN-HCT	02246955	25 MG; 160 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
DIOVAN-HCT	02308908	12.5 MG; 320 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
DIOVAN-HCT	02308916	25 MG; 320 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
SANDOZ VALSARTAN HCT	02356694	80 MG; 12.5 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ VALSARTAN HCT	02356708	12.5 MG; 160 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ VALSARTAN HCT	02356716	25 MG; 160 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ VALSARTAN HCT	02356724	320 MG; 12.5 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ VALSARTAN HCT	02356732	320 MG; 25 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
TEVA-VALSARTAN/HCTZ	02356996	12.5 MG; 80 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-VALSARTAN/HCTZ	02357003	12.5 MG; 160 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-VALSARTAN/HCTZ	02357011	25 MG; 160 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-VALSARTAN/HCTZ	02357038	12.5 MG; 320 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-VALSARTAN/HCTZ	02357046	320 MG; 25 MG	TABLET · ORAL	TEVA CANADA LIMITED
VALSARTAN HCT	02367009	80 MG; 12.5 MG	TABLET · ORAL	SANIS HEALTH INC
VALSARTAN HCT	02367017	12.5 MG; 160 MG	TABLET · ORAL	SANIS HEALTH INC
VALSARTAN HCT	02367025	160 MG; 25 MG	TABLET · ORAL	SANIS HEALTH INC
VALSARTAN HCT	02367033	320 MG; 12.5 MG	TABLET · ORAL	SANIS HEALTH INC
VALSARTAN HCT	02367041	25 MG; 320 MG	TABLET · ORAL	SANIS HEALTH INC

7 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DIOVAN HCT 160-12.5 MG TAB	$11.47643	per EA	23 Sep 2026
US NADAC	DIOVAN HCT 320-25 MG TABLET	$16.37958	per EA	23 Sep 2026
US NADAC	DIOVAN HCT 80-12.5 MG TABLET	$10.5648	per EA	7 Jan 2026
US NADAC	VALSARTAN-HYDROCHLOROTHIAZIDE 160-12.5 MG TAB	$0.10137	per EA	23 Sep 2026
US NADAC	VALSARTAN-HYDROCHLOROTHIAZIDE 160-25 MG TAB	$0.12141	per EA	23 Sep 2026
US NADAC	VALSARTAN-HYDROCHLOROTHIAZIDE 320-12.5 MG TAB	$0.18604	per EA	23 Sep 2026
US NADAC	VALSARTAN-HYDROCHLOROTHIAZIDE 320-25 MG TAB	$0.1916	per EA	23 Sep 2026
US NADAC	VALSARTAN-HYDROCHLOROTHIAZIDE 80-12.5 MG TAB	$0.09732	per EA	23 Sep 2026
NHS Drug Tariff	Valsartan 160mg / Hydrochlorothiazide 12.5mg tablets	£9.80	28 tablet	1 Oct 2026
NHS Drug Tariff	Valsartan 160mg / Hydrochlorothiazide 25mg tablets	£29.72	28 tablet	1 Oct 2026
NHS Drug Tariff	Valsartan 80mg / Hydrochlorothiazide 12.5mg tablets	£8.36	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.