Is Bisoprolol + Hydrochlorothiazide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Bisoprolol + Hydrochlorothiazide, including CARDEX PLUS 10/25 mg F.C TABLETS (25,10 mg,mg, Film-coated tablet, SAR 38.85); CARDEX PLUS 5/12.5 mg F.C TABLETS (12.5,5 mg,mg, Film-coated tablet, SAR 25.25); CARDICOR PLUS 5/12.5MG FILM COATED TABLET (12.5,5 mg,mg, Film-coated tablet, SAR 22.70); CONCOR 5 PLUS F.C. TABLETS (12.5,5 mg,mg, Film-coated tablet, SAR 19.50); SELECTA PLUS 5MG-12.5MG F.C. TABLETS (12.5,5 mg,mg, Film-coated tablet, SAR 19.55).

Is Bisoprolol + Hydrochlorothiazide approved by the US FDA?

Drugs@FDA lists 16 application product lines for Bisoprolol + Hydrochlorothiazide, including ZIAC (Prescription); BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (Prescription); BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (Prescription); BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (Prescription); BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (Prescription).

Active substances

Bisoprolol + Hydrochlorothiazide

SFDA 11
US FDA 16
US price lines 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CARDEX PLUS 10/25 mg F.C TABLETS	25,10 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 38.85	Generic · Prescription	ACINO PHARMA AG	Valid
CARDEX PLUS 5/12.5 mg F.C TABLETS	12.5,5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 25.25	Generic · Prescription	ACINO PHARMA AG	Valid
CARDICOR PLUS 5/12.5MG FILM COATED TABLET	12.5,5 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 22.70	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
CONCOR 5 PLUS F.C. TABLETS	12.5,5 mg,mg	Film-coated tablet · Oral use	20 Blister	SAR 19.50	NCE · Prescription	Merck Healthcare KGAA	Valid
SELECTA PLUS 5MG-12.5MG F.C. TABLETS	12.5,5 mg,mg	Film-coated tablet · Oral use	20 Blister	SAR 19.55	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
BITROL PLUS 10/25 mg film-coated tablet	10, 25 mg	Film-coated tablet · Oral use	30 Blister	SAR 34.95	Generic · Prescription	PFIZER SAUDI LIMITED	Withdrawn by MAH · Not Marketed
BITROL PLUS 5/12.5 mg film-coated tablet	5, 12.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 20.45	Generic · Prescription	PFIZER SAUDI LIMITED	Withdrawn by MAH · Not Marketed
CONCOR 10 PLUS F.C. TABLETS	10, 25 mg	Film-coated tablet · Oral use	30 Blister	SAR 39.85	NCE · Prescription	Merck Healthcare KGaA	Withdrawn by MAH · Not Marketed
LODOZ 10-6.25MG F.C. TABLETS	10, 6.25 mg	Film-coated tablet · Oral use	30 Blister	SAR 29.00	Generic · Prescription	MERCK SANTE	Withdrawn by MAH · Not Marketed
LODOZ 2.5-6.25MG F.C. TABLETS	2.5, 6.25 mg	Film-coated tablet · Oral use	30 Blister	SAR 17.10	Generic · Prescription	MERCK SANTE	Withdrawn by MAH · Not Marketed
LODOZ 5-6.25MG F.C. TABLETS	5, 6.25 mg	Film-coated tablet · Oral use	30 Blister	SAR 29.00	Generic · Prescription	MERCK SANTE	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
ZIAC	5MG;6.25MG; 10MG;6.25MG; 2.5MG;6.25MG	tablet · oral	TEVA BRANDED PHARM	Prescription	26 Mar 1993
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	EPIC PHARMA LLC	Prescription	25 Sep 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	MYLAN	Prescription	25 Sep 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	UNICHEM	Prescription	28 Jul 2010
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	EDENBRIDGE PHARMS	Prescription	9 Jul 2020
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	NOVITIUM PHARMA	Prescription	4 Nov 2021
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	26 Jan 2022
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	CADILA	Prescription	4 Nov 2022
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	21 Jan 2026
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	UNIQUE PHARM	Prescription	24 Mar 2026
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	WATSON LABS TEVA	Discontinued	25 Sep 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 10MG;6.25MG; 5MG;6.25MG	tablet · oral	CHARTWELL RX	Discontinued	25 Sep 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	ACTAVIS ELIZABETH	Discontinued	25 Sep 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	IVAX SUB TEVA PHARMS	Discontinued	27 Sep 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	5MG;6.25MG; 2.5MG;6.25MG; 10MG;6.25MG	tablet · oral	APOTHECON	Discontinued	27 Dec 2000
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	2.5MG;6.25MG; 5MG;6.25MG; 10MG;6.25MG	tablet · oral	TEVA	Discontinued	19 Jan 2001

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BISOPROLOL-HYDROCHLOROTHIAZIDE 10-6.25 MG TAB	$0.20936	per EA	23 Sep 2026
US NADAC	BISOPROLOL-HYDROCHLOROTHIAZIDE 2.5-6.25 MG TB	$0.21329	per EA	23 Sep 2026
US NADAC	BISOPROLOL-HYDROCHLOROTHIAZIDE 5-6.25 MG TAB	$0.22026	per EA	23 Sep 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.