Is Hydrochlorothiazide + Olmesartan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 22 valid registrations of Hydrochlorothiazide + Olmesartan, including CO-OLMEPRESS 20 mg/12.5 mg F.C. Tablet (20,12.5 mg,mg, Film-coated tablet, SAR 48.80); CO-OLMEPRESS 40 mg/12.5 mg F.C. Tablet (40,12.5 mg,mg, Film-coated tablet, SAR 66.15); CO-OLMEPRESS 40 mg/25 mg F.C. Tablet (40,25 mg,mg, Film-coated tablet, SAR 66.15); Erastapecs Plus 20/12.5MG F.C.TABLET (20,12.5 mg,mg, Film-coated tablet, SAR 47.95); Erastapecs Plus 40/12.5MG F.C.TABLET (40,12.5 mg,mg, Film-coated tablet, SAR 63.80).

Is Hydrochlorothiazide + Olmesartan approved by the US FDA?

Drugs@FDA lists 17 application product lines for Hydrochlorothiazide + Olmesartan, including BENICAR HCT (Prescription); OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (Prescription); OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (Prescription); OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (Prescription); OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (Prescription).

Active substances

Hydrochlorothiazide + Olmesartan

SFDA 22
US FDA 17
Health Canada 21
US price lines 4
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
CO-OLMEPRESS 20 mg/12.5 mg F.C. Tablet	20,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 48.80	Generic · Prescription	LABORATORIOS CINFA SA	Valid
CO-OLMEPRESS 40 mg/12.5 mg F.C. Tablet	40,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 66.15	Generic · Prescription	LABORATORIOS CINFA SA	Valid
CO-OLMEPRESS 40 mg/25 mg F.C. Tablet	40,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 66.15	Generic · Prescription	LABORATORIOS CINFA SA	Valid
Erastapecs Plus 20/12.5MG F.C.TABLET	20,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 47.95	Generic · Prescription	Apex Pharma	Valid
Erastapecs Plus 40/12.5MG F.C.TABLET	40,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 63.80	Generic · Prescription	Apex Pharma	Valid
NORMATEC PLUS 20/12.5 mg film-coated tablet	20,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 59.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
NORMATEC PLUS 40/12.5 mg film-coated tablet	40,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 78.80	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
NORMATEC PLUS 40/25 mg film-coated tablet	40,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 78.80	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
OLMAZIDE 20/12.5MG F.C.TABLET	20,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 47.95	Generic · Prescription	Saudi Amarox	Valid
OLMAZIDE 40/12.5MG	40,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 63.80	Generic · Prescription	Saudi Amarox	Valid
OLMAZIDE 40/25MG	40,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 63.80	Generic · Prescription	Saudi Amarox	Valid
OLMETEC PLUS 20MG-12.5MG F.C. TABLETS	20,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 65.60	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
OLMETEC PLUS 40MG-12.5MG F.C. TABLETS	40,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 87.30	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
OLMETEC PLUS 40MG-25MG F.C. TABLETS	40,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 87.30	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Olcontro HCT	20,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 33.55	Generic · Prescription	Med City Pharma	Valid
Olcontro HCT	40,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 44.65	Generic · Prescription	Med City Pharma	Valid
Olmetrol Plus	40,12.5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 63.80	Generic · Prescription	RIYADH PHARMA	Valid
Olmetrol Plus	20,12.50 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 47.95	Generic · Prescription	RIYADH PHARMA	Valid
Olmetrol Plus	40,25 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 63.80	Generic · Prescription	RIYADH PHARMA	Valid
Olsar Plus	40,25 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 70.90	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Olsar Plus	40,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 70.90	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Olsar Plus	20,12.5 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 53.30	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid

Indications — CHI Daman Drug Formulary

HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
BENICAR HCT	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	COSETTE	Prescription	5 Jun 2003
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	ALEMBIC	Prescription	24 Apr 2017
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	AUROBINDO PHARMA	Prescription	24 Apr 2017
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	PRINSTON INC	Prescription	24 Apr 2017
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	ACCORD HLTHCARE	Prescription	7 Feb 2019
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 25MG;40MG; 12.5MG;40MG	tablet · oral	PHARMAZONE	Prescription	17 Sep 2019
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	MACLEODS PHARMS	Prescription	1 Jun 2023
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	ALKEM LABS LTD	Prescription	11 Jul 2024
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	HETERO LABS LTD V	Prescription	25 Jul 2025
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	HANGZHOU BINJIANG	Prescription	20 Aug 2025
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	MSN	Prescription	26 Sep 2025
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	SCIEGEN PHARMS	Prescription	31 Mar 2026
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	MICRO LABS	Prescription	13 Apr 2026
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	NATCO PHARMA USA	Discontinued	26 Oct 2016
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	TEVA PHARMS USA	Discontinued	24 Apr 2017
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	TORRENT	Discontinued	3 May 2017
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG; 12.5MG;40MG; 25MG;40MG	tablet · oral	ZYDUS PHARMS	Discontinued	24 Feb 2023

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-OLMESARTAN HCTZ	02468948	20 MG; 12.5 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-OLMESARTAN HCTZ	02468956	40 MG; 12.5 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-OLMESARTAN HCTZ	02468964	40 MG; 25 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
AURO-OLMESARTAN HCTZ	02476487	20 MG; 12.5 MG	TABLET · ORAL	AURO PHARMA INC
AURO-OLMESARTAN HCTZ	02476495	12.5 MG; 40 MG	TABLET · ORAL	AURO PHARMA INC
AURO-OLMESARTAN HCTZ	02476509	25 MG; 40 MG	TABLET · ORAL	AURO PHARMA INC
GLN-OLMESARTAN HCTZ	02475707	12.5 MG; 20 MG	TABLET · ORAL	GLENMARK PHARMACEUTICALS CANADA INC.
GLN-OLMESARTAN HCTZ	02475715	12.5 MG; 40 MG	TABLET · ORAL	GLENMARK PHARMACEUTICALS CANADA INC.
GLN-OLMESARTAN HCTZ	02475723	25 MG; 40 MG	TABLET · ORAL	GLENMARK PHARMACEUTICALS CANADA INC.
NRA-OLMESARTAN HCTZ	02508273	12.5 MG; 20 MG	TABLET · ORAL	NORA PHARMA INC
NRA-OLMESARTAN HCTZ	02508281	12.5 MG; 40 MG	TABLET · ORAL	NORA PHARMA INC
NRA-OLMESARTAN HCTZ	02508303	40 MG; 25 MG	TABLET · ORAL	NORA PHARMA INC
OLMESARTAN/HCTZ	02509601	12.5 MG; 20 MG	TABLET · ORAL	SANIS HEALTH INC
OLMESARTAN/HCTZ	02509628	40 MG; 25 MG	TABLET · ORAL	SANIS HEALTH INC
OLMESARTAN/HCTZ	02509636	12.5 MG; 40 MG	TABLET · ORAL	SANIS HEALTH INC
OLMETEC PLUS	02319616	12.5 MG; 20 MG	TABLET · ORAL	ORGANON CANADA INC.
OLMETEC PLUS	02319624	12.5 MG; 40 MG	TABLET · ORAL	ORGANON CANADA INC.
OLMETEC PLUS	02319632	40 MG; 25 MG	TABLET · ORAL	ORGANON CANADA INC.
TEVA-OLMESARTAN / HCTZ	02443112	12.5 MG; 20 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-OLMESARTAN / HCTZ	02443120	40 MG; 12.5 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-OLMESARTAN / HCTZ	02443139	40 MG; 25 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BENICAR HCT 40-12.5 MG TABLET	$17.20133	per EA	1 Jul 2026
US NADAC	OLMESARTAN-HYDROCHLOROTHIAZIDE 20-12.5 MG TAB	$0.16502	per EA	23 Sep 2026
US NADAC	OLMESARTAN-HYDROCHLOROTHIAZIDE 40-12.5 MG TAB	$0.21959	per EA	23 Sep 2026
US NADAC	OLMESARTAN-HYDROCHLOROTHIAZIDE 40-25 MG TAB	$0.20907	per EA	23 Sep 2026
NHS Drug Tariff	Olmesartan medoxomil 20mg / Hydrochlorothiazide 12.5mg tablets	£12.95	28 tablet	1 Oct 2026
NHS Drug Tariff	Olmesartan medoxomil 20mg / Hydrochlorothiazide 25mg tablets	£12.95	28 tablet	1 Oct 2026
NHS Drug Tariff	Olmesartan medoxomil 40mg / Hydrochlorothiazide 12.5mg tablets	£17.50	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.