Is Amiloride + Hydrochlorothiazide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Amiloride + Hydrochlorothiazide, including AMURETIC 5MG/50MG TAB (50,5 mg,mg, Tablet, SAR 8.75).

Is Amiloride + Hydrochlorothiazide approved by the US FDA?

Drugs@FDA lists 7 application product lines for Amiloride + Hydrochlorothiazide, including AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (Prescription); AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (Prescription); MODURETIC 5-50 (Discontinued); HYDRO-RIDE (Discontinued); AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (Discontinued).

Active substances

Amiloride + Hydrochlorothiazide

SFDA 3
US FDA 7
Health Canada 1
US price lines 1
NHS prices 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AMURETIC 5MG/50MG TAB	50,5 mg,mg	Tablet · Oral use	20 Blister	SAR 8.75	Generic · Prescription	DAR ALDAWA	Valid
MODURETIC 5-50MG TABLETS	50,5 mg,mg	Tablet · Oral use	30 Blister	SAR 17.60	Generic · Prescription	Algorithm SAL	Suspended
APO-AMILZIDE	5, 50 mg	Tablet · Oral use	30 Blister	SAR 15.80	Generic · Prescription	APOTEX	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

CONGESTIVE HEART FAILURE; HYPERTENSION; PULMONARY ARTERIAL HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	EQ 5MG ANHYDROUS;50MG	tablet · oral	BARR	Prescription	10 May 1988
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	EQ 5MG ANHYDROUS;50MG	tablet · oral	RISING	Prescription	31 Oct 1991
MODURETIC 5-50	EQ 5MG ANHYDROUS;50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	MERCK	Discontinued	5 Oct 1981
HYDRO-RIDE	EQ 5MG ANHYDROUS;50MG	tablet · oral	PAR PHARM	Discontinued	6 Aug 1986
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	EQ 5MG ANHYDROUS;50MG	tablet · oral	TEVA	Discontinued	15 Jul 1987
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	EQ 5MG ANHYDROUS;50MG	tablet · oral	WATSON LABS	Discontinued	19 Jul 1991
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	EQ 5MG ANHYDROUS;50MG	tablet · oral	CHARTWELL RX	Discontinued	27 Nov 1991

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AA-AMILZIDE	00784400	5 MG; 50 MG	TABLET · ORAL	AA PHARMA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AMILORIDE HCL-HYDROCHLOROTHIAZIDE 5-50 MG TAB	$0.44985	per EA	23 Sep 2026
NHS Drug Tariff	Co-amilozide 2.5mg/25mg tablets	£92.17	28 tablet	1 Oct 2026
NHS Drug Tariff	Co-amilozide 5mg/50mg tablets	£28.35	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.