Hydrochlorothiazide

Manages hypertension. Sold as Esidrix, Hydrodiuril, Oretic, Microzide, Inzirqo. Every FDA application for this active ingredient: 5 branded and 99 generic.

As of Nov 15, 2026, FDA lists 104 applications for Hydrochlorothiazide (sold as Esidrix, Hydrodiuril, Oretic and others), first approved Feb 12, 1959, with 1 new use approved and 0 published complete response letters.

First approved: Feb 12, 1959
Applications: 104
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $79.4M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Hydrochlorothiazide	Part D	$79.4M	-2%	4,895,170
Inzirqo	Part D	$13K	New	16

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

HYDROCHLOROTHIAZIDE 12.5 MG CP: $0.027 per unitGeneric · -10% in a year
HYDROCHLOROTHIAZIDE 12.5 MG TB: $0.036 per unitGeneric · -13% in a year
HYDROCHLOROTHIAZIDE 25 MG TAB: $0.011 per unitGeneric · -8% in a year
HYDROCHLOROTHIAZIDE 50 MG TAB: $0.031 per unitGeneric · -10% in a year
INZIRQO 10 MG/ML ORAL SUSP: $4.47 per MLBrand · new this year

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Hydrochlorothiazide Capsule	To Be Discontinued	Nov 19, 2025	Nov 19, 2025

Clinical Trials

25 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Early Mineralocorticoid Receptor Antagonist Therapy for Low-Renin Essential HypertensionHypertension (HTN), Low-Renin Essential Hypertension · China National Center for Cardiovascular Diseases	Phase 4	Not yet recruiting	Nov 12, 2026
SPIRO-First: A Pragmatic Primary Care-Embedded Pilot Trial of Renin-Guided First-Line Antihypertensive TherapyHypertension · Ottawa Hospital Research Institute	Phase 4	Not yet recruiting	Jul 7, 2026
Comparative Effectiveness of Dual Antihypertensive Regimens in Patients After Percutaneous Coronary InterventionHypertension, Coronary Arterial Disease · National Medical Research Center for Therapy and Preventive Medicine	Not applicable	Recruiting	Jul 6, 2026
Vertebrobasilar Dolichoectasia Treatment With AmilorideVertebrobasilar Dolichoectasia · Huashan Hospital	Phase 2	Not yet recruiting	Jun 8, 2026
TACTIC-HF: Sequential Diuretic Strategies in Ambulatory Worsening Heart FailureAcute Heart Failure (AHF) · Lucrecia Maria Burgos	Phase 4	Not yet recruiting	May 18, 2026
POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart FailureAcute Heart Failure (AHF), Congestive Heart Failure Acute · Hospital de Clinicas de Porto Alegre	Phase 2 / Phase 3	Not yet recruiting	Mar 13, 2026
Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure ControlIntracerebral Hemorrhage · The University of Hong Kong	Not applicable	Recruiting	Mar 9, 2026
Blood Pressure Control With Thiazide Diuretics in Peritoneal Dialysis PatientsHypertension, Peritoneal Dialysis · Chinese University of Hong Kong	Phase 4	Recruiting	Dec 9, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 12, 1959	EsidrixNDA 11793 · New molecular entity	Novartis	39	Discontinued
Feb 24, 1959	HydrodiurilNDA 11835 · New formulation or manufacturer	Merck	12	Discontinued
Jul 6, 1959	OreticNDA 11971 · New formulation or manufacturer	Abbvie	9	Discontinued
Jan 12, 1973	HydrochlorothiazideANDA 83177	Ivax Sub Teva Pharms	36	Marketed
Jul 2, 1974	HydrochlorothiazideANDA 83809	Whiteworth Town Plsn	1	Discontinued
Oct 3, 1974	HydrochlorothiazideANDA 83972	Sun Pharm Industries	22	Discontinued
Jan 24, 1975	HydrochlorothiazideANDA 83232	Watson Labs Teva	23	Discontinued
Sep 24, 1975	HydrochlorothiazideANDA 84658	Ivax Sub Teva Pharms	1	Discontinued
Jun 24, 1976	HydrochlorothiazideANDA 84325	Lannett Co Inc	9	Discontinued
Jun 24, 1976	HydrochlorothiazideANDA 84324	Lannett Co Inc	10	Discontinued
Sep 21, 1976	HydrochlorothiazideANDA 84776	Inwood Labs	0	Discontinued
Dec 17, 1976	HydrochlorothiazideANDA 84912	Chartwell Rx	28	Discontinued
Jan 31, 1977	HydrochlorothiazideANDA 84878	Hikma	15	Discontinued
Mar 21, 1977	HydrochlorothiazideANDA 83965	Chartwell Rx	18	Discontinued
Apr 1, 1977	HydrochlorothiazideANDA 84771	Barr	2	Discontinued
Apr 27, 1977	HydrochlorothiazideANDA 85233	Watson Labs	0	Discontinued
May 3, 1977	ZideANDA 83925	Solvay	0	Discontinued
May 3, 1977	HydrochlorothiazideANDA 85232	Watson Labs	0	Discontinued
Jun 1, 1977	HydrochlorothiazideANDA 85323	Solvay	0	Discontinued
Jun 2, 1977	HydrochlorothiazideANDA 85672	Abc Holding	13	Discontinued
Jul 15, 1977	HydrochlorothiazideANDA 85098	Impax Labs	7	Discontinued
Aug 17, 1977	HydrochlorothiazideANDA 85683	Chartwell Rx	16	Discontinued
Aug 19, 1977	HydrochlorothiazideANDA 83607	Impax Labs	0	Discontinued
Sep 1, 1977	HydrochlorothiazideANDA 85022	Ivax Sub Teva Pharms	23	Discontinued
Jan 20, 1978	HydrochlorothiazideANDA 85182	Heritage	8	Marketed
Jan 26, 1978	HydrochlorothiazideANDA 85347	Whiteworth Town Plsn	1	Discontinued
Jul 13, 1978	HydrochlorothiazideANDA 85004	Roxane	2	Discontinued
Jul 13, 1978	HydrochlorothiazideANDA 85005	Roxane	0	Discontinued
Jul 17, 1978	HydrochlorothiazideANDA 86087	Watson Labs	0	Discontinued
Oct 5, 1978	HydrochlorothiazideANDA 86594	Watson Labs	0	Discontinued
Oct 11, 1978	HydrochlorothiazideANDA 86597	Pvt Form	0	Discontinued
Mar 12, 1979	HydrochlorothiazideANDA 85219	Aurolife Pharma LLC	8	Discontinued
Nov 5, 1980	HydrochlorothiazideANDA 87059	Oxford Pharms	15	Marketed
Nov 5, 1980	HydrochlorothiazideANDA 87060	Tp Anda Holdings	3	Discontinued
Nov 5, 1980	HydrochlorothiazideANDA 87068	Oxford Pharms	17	Marketed
Feb 9, 1981	HydrochlorothiazideANDA 87002	Watson Labs	0	Discontinued
Aug 20, 1981	HydrochlorothiazideANDA 85208	Actavis Elizabeth	19	Discontinued
Aug 20, 1981	HydrochlorothiazideANDA 85054	Actavis Elizabeth	21	Discontinued
Dec 7, 1981	HydrochlorothiazideANDA 87610	Vangard	1	Discontinued
Mar 9, 1982	HydrochlorothiazideANDA 87565	Chartwell Rx	21	Discontinued
Apr 19, 1982	HydrochlorothiazideANDA 87827	Usl Pharma	0	Discontinued
Apr 19, 1982	HydrochlorothiazideANDA 87752	Usl Pharma	0	Discontinued
Jul 2, 1984	Hydrochlorothiazide IntensolANDA 88588	Roxane	0	Discontinued
Jul 2, 1984	HydrochlorothiazideANDA 88587	Roxane	10	Discontinued
Dec 28, 1984	HydrochlorothiazideANDA 88827	Superpharm	2	Discontinued
Dec 28, 1984	HydrochlorothiazideANDA 88828	Superpharm	2	Discontinued
Dec 28, 1984	HydrochlorothiazideANDA 88829	Superpharm	2	Discontinued
Feb 7, 1985	HydrochlorothiazideANDA 88923	Teva	1	Discontinued
Feb 7, 1985	HydrochlorothiazideANDA 88924	Teva	1	Discontinued
Jan 24, 1992	HydrochlorothiazideANDA 81189	Watson Labs	4	Discontinued
Jan 24, 1992	HydrochlorothiazideANDA 81190	Watson Labs	5	Discontinued
Dec 27, 1996	MicrozideNDA 20504 · New dosage form	Teva Branded Pharm	6	Marketed
Jan 28, 2000	HydrochlorothiazideANDA 75640	Quagen	3	Discontinued
Mar 29, 2002	HydrochlorothiazideANDA 40412	Prinston	2	Discontinued
Sep 17, 2002	HydrochlorothiazideANDA 75907	Prinston	2	Marketed
Jul 13, 2005	HydrochlorothiazideANDA 77005	Ivax Sub Teva Pharms	2	Discontinued
Jan 23, 2007	HydrochlorothiazideANDA 40735	Pharmobedient	2	Discontinued
Jan 23, 2007	HydrochlorothiazideANDA 40770	Pharmobedient	2	Discontinued
Feb 27, 2007	HydrochlorothiazideANDA 40707	Actavis Elizabeth	2	Marketed
Mar 16, 2007	HydrochlorothiazideANDA 40702	Leading	4	Marketed
Mar 27, 2007	HydrochlorothiazideANDA 40810	Sun Pharm Inds Inc	1	Discontinued
Jul 20, 2007	HydrochlorothiazideANDA 40780	Aurobindo Pharma	3	Marketed
Jul 20, 2007	HydrochlorothiazideANDA 40807	Ipca Labs Ltd	3	Discontinued
Sep 4, 2007	HydrochlorothiazideANDA 40809	Jubilant Cadista	1	Discontinued
Sep 19, 2007	HydrochlorothiazideANDA 78164	Aurobindo Pharma	2	Marketed
Oct 3, 2007	HydrochlorothiazideANDA 40774	Apotex	2	Discontinued
Nov 26, 2007	HydrochlorothiazideANDA 77885	Hikma	2	Discontinued
Feb 11, 2008	HydrochlorothiazideANDA 78391	Jubilant Cadista	1	Marketed
May 16, 2008	HydrochlorothiazideANDA 78389	Apotex	1	Discontinued
May 30, 2008	HydrochlorothiazideANDA 40857	Sun Pharm Inds Inc	1	Discontinued
Aug 15, 2008	HydrochlorothiazideANDA 40907	Unichem	3	Marketed
Apr 2, 2009	HydrochlorothiazideANDA 79237	Ipca Labs Ltd	2	Discontinued
Jan 19, 2010	HydrochlorothiazideANDA 90510	Unichem	2	Marketed
Nov 30, 2010	HydrochlorothiazideANDA 200645	Alembic Pharms Ltd	2	Discontinued
Jan 27, 2012	HydrochlorothiazideANDA 91662	Chartwell Molecular	0	Discontinued
Sep 24, 2012	HydrochlorothiazideANDA 202556	Accord Hlthcare	2	Marketed
Apr 7, 2014	HydrochlorothiazideANDA 90651	Sun Pharm Inds Inc	0	Discontinued
Jul 23, 2014	HydrochlorothiazideANDA 203018	Sciegen Pharms	1	Marketed
Jan 14, 2019	HydrochlorothiazideANDA 203561	Sciegen Pharms	2	Marketed
Jan 28, 2025	InzirqoNDA 219141 · New dosage form	Novitium Pharma	0	Marketed
Oct 7, 2026	HydrochlorothiazideANDA 218248	Rubicon Research	0	Marketed
—	HydrochlorothiazideANDA 83456	Watson Labs	0	Discontinued
—	HydrochlorothiazideANDA 83899	Aurolife Pharma LLC	0	Discontinued
—	HydrochlorothiazideANDA 85067	Inwood Labs	0	Discontinued
—	HydrochlorothiazideANDA 83554	Alra	2	Discontinued
—	HydrochlorothiazideANDA 83458	Watson Labs	0	Discontinued
—	Hydro-DANDA 83891	Halsey	0	Discontinued
—	HydrochlorothiazideANDA 84029	Impax Labs	0	Discontinued
—	HydrochlorothiazideANDA 84135	Heather	0	Discontinued
—	HydrochlorothiazideANDA 84536	Roxane	0	Discontinued
—	HydrochlorothiazideANDA 84880	Mylan	0	Discontinued
—	HydrochlorothiazideANDA 84899	West Ward	0	Discontinued
—	HydrochlorothiazideANDA 85099	Watson Labs	0	Discontinued
—	HydrochlorothiazideANDA 85112	Mylan	0	Discontinued
—	HydrochlorothiazideANDA 85152	Elkins Sinn	0	Discontinued
—	HydrochlorothiazideANDA 86192	Mast Mm	0	Discontinued
—	HydrochlorothiazideANDA 86369	Alra	2	Discontinued
—	Hydro-DANDA 86504	Halsey	0	Discontinued
—	HydrochlorothiazideANDA 87540	Ascot	0	Discontinued
—	HydrochlorothiazideANDA 87539	Ascot	0	Discontinued
—	HydrochlorothiazideANDA 87586	Warner Chilcott	0	Discontinued
—	HydrochlorothiazideANDA 87587	Warner Chilcott	0	Discontinued
—	HydrochlorothiazideANDA 87638	Vangard	0	Discontinued
—	HydrochlorothiazideANDA 89661	Morton Grove	0	Discontinued

Show all 104

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA