Is Hydrochlorothiazide + Spironolactone approved by the US FDA?

Drugs@FDA lists 20 application product lines for Hydrochlorothiazide + Spironolactone, including ALDACTAZIDE (Prescription); SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (Prescription); SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (Prescription); SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE (Prescription); ALDACTAZIDE (Discontinued).

Active substances

Hydrochlorothiazide + Spironolactone

US FDA 20
Health Canada 2
US price lines 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
ALDACTAZIDE	25MG;25MG	tablet · oral	PFIZER	Prescription	27 Jan 1961
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	MYLAN	Prescription	3 Aug 1979
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	SUN PHARM INDUSTRIES	Prescription	2 Jul 1987
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	RUBICON RESEARCH	Prescription	10 Sep 2026
ALDACTAZIDE	50MG;50MG	tablet · oral	PFIZER	Discontinued	27 Jan 1961
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	IVAX PHARMS	Discontinued	7 May 1980
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	CHARTWELL RX	Discontinued	10 Jul 1980
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	MUTUAL PHARM	Discontinued	16 Apr 1981
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	WATSON LABS	Discontinued	24 Nov 1981
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	VANGARD	Discontinued	14 Dec 1981
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	SUPERPHARM	Discontinued	26 Aug 1985
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	PUREPAC PHARM	Discontinued	6 Nov 1985
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	WATSON LABS	Discontinued
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	WATSON LABS	Discontinued
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	LEDERLE	Discontinued
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	UPSHER SMITH	Discontinued
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	USL PHARMA	Discontinued
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	PARKE DAVIS	Discontinued
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	ASCOT	Discontinued
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	25MG;25MG	tablet · oral	PUREPAC PHARM	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TEVA-SPIRONOLACTONE/HCTZ	00613231	25 MG; 25 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-SPIRONOLACTONE/HCTZ	00657182	50 MG; 50 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	SPIRONOLACTONE-HYDROCHLOROTHIAZIDE 25-25 TAB	$0.48325	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.