Chlorthalidone

Treats hypertension. Sold as Hygroton, Thalitone, Hemiclor. Every FDA application for this active ingredient: 3 branded and 61 generic.

As of Nov 14, 2026, FDA lists 64 applications for Chlorthalidone (sold as Hygroton, Thalitone, Hemiclor), first approved Apr 7, 1960, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 7, 1960
Applications: 64
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $43.5M

Medicare Spending

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


Chlorthalidone	Part D	$43.2M	-11%	829,741
Hemiclor	Part D	$167K	New	1,785
Thalitone	Part D	$160K	-72%	591

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

CHLORTHALIDONE 25 MG TABLET: $0.073 per unitGeneric · -14% in a year
CHLORTHALIDONE 50 MG TABLET: $0.117 per unitGeneric · -7% in a year
THALITONE 15 MG TABLET: $3.54 per unitBrand · 0% in a year
HEMICLOR 12.5 MG TABLET: $0.957 per unitBrand · +0% in a year

Clinical Trials

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


Blood Pressure Control and Safety of Ex-one or Ex-one Plus in Essential HypertensionEssential Hypertension · HK inno.N Corporation	—	Recruiting	Nov 12, 2026
Effectiveness and Safety of Sequential Triple Combination Therapy (Amlodipine/Losartan/Chlorthalidone) in Korean Patients With HypertensionHypertension · Hanmi Pharmaceutical Company Limited	—	Recruiting	Aug 25, 2026
LOw DosE Spironolactone, chlorThAlidone oR Combination in CKD TrialHypertension Treated With Antihypertensive Drugs, Chronic Kidney Disease, 3B and 4 · VA Office of Research and Development	Phase 2	Not yet recruiting	Jun 12, 2026
Cardiac Effects of Mineralocorticoid Receptor Antagonism After Hypertensive Disorders of PregnancyHypertension · Massachusetts General Hospital	Phase 2	Recruiting	Nov 20, 2025
CaOx Stone PreventionKidney Stones · Icahn School of Medicine at Mount Sinai	Phase 4	Recruiting	Nov 10, 2025
Arterial Stiffness and Blood PressureHypertension, Vascular Stiffness · VA Office of Research and Development	Not applicable	Recruiting	Jul 11, 2024
Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential HypertensionEssential Hypertension · Yuhan Corporation	—	Active, not recruiting	Feb 28, 2024
Indapamide and Chlorthalidone to Reduce Urine Supersaturation for Kidney Stone PreventionKidney Stone · Insel Gruppe AG, University Hospital Bern	Phase 2	Recruiting	Nov 1, 2023

Applications

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


Apr 7, 1960	HygrotonNDA 12283 · New molecular entity	Sanofi Aventis US	0	Discontinued
Feb 26, 1981	ChlorthalidoneANDA 86831	Mylan	15	Marketed
Mar 5, 1981	ChlorthalidoneANDA 87292	Mutual Pharm	20	Discontinued
Mar 5, 1981	ChlorthalidoneANDA 87293	Mutual Pharm	21	Discontinued
Mar 6, 1981	ChlorthalidoneANDA 87364	Abbott	3	Discontinued
Mar 6, 1981	ChlorthalidoneANDA 87384	Abbott	3	Discontinued
Mar 11, 1981	ChlorthalidoneANDA 87311	Kv Pharm	2	Discontinued
Mar 11, 1981	ChlorthalidoneANDA 87312	Kv Pharm	2	Discontinued
Apr 3, 1981	ChlorthalidoneANDA 87450	Dava Pharms Inc	10	Discontinued
Apr 3, 1981	ChlorthalidoneANDA 87451	Dava Pharms Inc	11	Discontinued
Apr 13, 1981	ChlorthalidoneANDA 87176	Ivax Pharms	11	Discontinued
May 1, 1981	ChlorthalidoneANDA 87381	Aiping Pharm Inc	21	Discontinued
Jun 24, 1981	ChlorthalidoneANDA 87555	Ivax Pharms	0	Discontinued
Aug 19, 1981	ChlorthalidoneANDA 87296	Ani Pharms	13	Discontinued
Aug 19, 1981	ChlorthalidoneANDA 87521	Watson Labs	13	Discontinued
Aug 25, 1981	ChlorthalidoneANDA 87082	Watson Labs	3	Discontinued
Aug 25, 1981	ChlorthalidoneANDA 87100	Watson Labs	21	Discontinued
Sep 16, 1981	ChlorthalidoneANDA 87689	Ani Pharms	18	Discontinued
Sep 16, 1981	ChlorthalidoneANDA 87706	Ani Pharms	14	Discontinued
Jul 14, 1982	ChlorthalidoneANDA 88012	Vangard	0	Discontinued
Feb 9, 1983	ChlorthalidoneANDA 87247	Superpharm	2	Discontinued
Mar 25, 1983	ChlorthalidoneANDA 88073	Vangard	0	Discontinued
Jan 9, 1984	ChlorthalidoneANDA 88164	Ani Pharms	11	Discontinued
Feb 27, 1984	ChlorthalidoneANDA 87947	Ivax Pharms	0	Discontinued
May 30, 1985	ChlorthalidoneANDA 88651	Cosette Pharms Nc	1	Discontinued
Sep 19, 1985	ChlorthalidoneANDA 88902	Barr Labs Inc	14	Discontinued
Sep 19, 1985	ChlorthalidoneANDA 88903	Barr Labs Inc	13	Discontinued
Jul 21, 1986	ChlorthalidoneANDA 89285	Mutual Pharm	13	Discontinued
Jul 21, 1986	ChlorthalidoneANDA 89286	Sun Pharm Industries	12	Marketed
Dec 20, 1988	ThalitoneNDA 19574 · New dosage form	Casper Pharma LLC	13	Marketed
Sep 16, 1994	ChlorthalidoneANDA 87118	Sandoz	8	Discontinued
Oct 27, 2005	ThalitoneANDA 88051	Monarch Pharms	7	Discontinued
Mar 30, 2017	ChlorthalidoneANDA 206904	Ingenus Pharms LLC	0	Marketed
May 24, 2018	ChlorthalidoneANDA 207222	Umedica	1	Marketed
Oct 12, 2018	ChlorthalidoneANDA 210742	Appco	0	Marketed
Feb 26, 2019	ChlorthalidoneANDA 211063	Chartwell Rx	0	Marketed
May 10, 2019	ChlorthalidoneANDA 207813	Zydus Pharms	0	Marketed
Jul 1, 2019	ChlorthalidoneANDA 207204	Amneal Pharms Co	0	Marketed
Aug 6, 2019	ChlorthalidoneANDA 211627	Unichem	0	Marketed
Feb 11, 2020	ChlorthalidoneANDA 213412	Alkem Labs Ltd	0	Marketed
Nov 27, 2020	ChlorthalidoneANDA 214129	Ajanta Pharma Ltd	0	Marketed
Jan 25, 2022	ChlorthalidoneANDA 209068	Sunny	0	Discontinued
Feb 9, 2022	ChlorthalidoneANDA 211320	Adaptis	0	Marketed
Feb 24, 2022	ChlorthalidoneANDA 212878	Pharmobedient	0	Marketed
Feb 24, 2022	ChlorthalidoneANDA 212875	Pharmobedient	0	Marketed
Aug 4, 2022	ChlorthalidoneANDA 215587	Mankind Pharma	0	Marketed
Aug 26, 2022	ChlorthalidoneANDA 216262	Alembic	0	Marketed
Nov 12, 2024	ChlorthalidoneANDA 209162	Ipca Labs Ltd	0	Marketed
Mar 17, 2025	HemiclorNDA 218647 · New dosage form	Prm Pharma	0	Marketed
Jul 1, 2026	ChlorthalidoneANDA 212229	Macleods Pharms	0	Marketed
—	ChlorthalidoneANDA 87029	Watson Labs	0	Discontinued
—	ChlorthalidoneANDA 87050	Watson Labs	0	Discontinued
—	ChlorthalidoneANDA 87473	Superpharm	0	Discontinued
—	ChlorthalidoneANDA 87515	Warner Chilcott	0	Discontinued
—	ChlorthalidoneANDA 87516	Warner Chilcott	0	Discontinued
—	ChlorthalidoneANDA 87698	Ascot	0	Discontinued
—	ChlorthalidoneANDA 87699	Ascot	0	Discontinued
—	ChlorthalidoneANDA 88139	Purepac Pharm	0	Discontinued
—	ChlorthalidoneANDA 88140	Purepac Pharm	0	Discontinued
—	ChlorthalidoneANDA 89051	Usl Pharma	0	Discontinued
—	ChlorthalidoneANDA 89052	Usl Pharma	0	Discontinued
—	ChlorthalidoneANDA 89591	Pioneer Pharms	0	Discontinued
—	ChlorthalidoneANDA 89738	Mutual Pharm	0	Discontinued
—	ChlorthalidoneANDA 89739	Mutual Pharm	0	Discontinued

Show all 64

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