Hydrocortisone

Controls severe or incapacitating allergic conditions. Sold as Hydrocortone, Cortef, Cortril, Cort-Dome, Hydrocortisone and 3 more. Every FDA application for this active ingredient: 12 branded and 131 generic.

As of Nov 13, 2026, FDA lists 143 applications for Hydrocortisone (sold as Hydrocortone, Cortef, Cortril and others), first approved Aug 5, 1952, with 0 new uses approved and 0 published complete response letters.

First approved: Aug 5, 1952
Applications: 143
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $90.6M

Medicare Spending

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


Hydrocortisone	Part D	$84.0M	+85%	1,491,448
Procto-Med HC	Part D	$3.8M	-9%	137,443
Proctozone-HC	Part D	$992K	+8%	28,024
Cortef	Part D	$577K	-6%	558
Cortifoam	Part D	$460K	-9%	426
Proctosol-HC	Part D	$295K	-2%	4,474
Hydrocortisone Acetate	Part D	$199K	+21130%	97
Ala-Scalp	Part D	$153K	+7%	205
Proctocort	Part D	$40K	+54%	53
Alkindi Sprinkle	Part D	$37K	New	0
Texacort	Part D	$33K	-37%	100
Anusol-HC	Part D	$24K	-5%	102
Ala-Cort	Part D	$6K	-32%	495
Cortenema	Part D	$0K	-100%	0

Clinical Trials

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


Emotional Reactivity in Severe Alcohol Use Disorder and Major Depressive Disorder Using Eye-tracking, Physiological, and Interoceptive Measures (ERAD)Alcohol Use Disorder, Major Depressive Disorder (MDD) · Université Catholique de Louvain	—	Recruiting	Nov 9, 2026
Relacorilant in Patients With Poorly Controlled Type 2 Diabetes and Autonomous Cortisol SecretionType 2 Diabetes, Hypercortisolism · The University of Texas Health Science Center at San Antonio	Phase 1 / Phase 2	Not yet recruiting	Nov 9, 2026
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 StudyMild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2) · Beckey Trinh	Phase 2	Not yet recruiting	Nov 6, 2026
Evaluation of the Effect of Time of Administration on the Activity on First Line of Pembrolizumab in Association With Carboplatin-pemetrexed in Metastatic Non-squamous Lung Cancer. A Randomised Multicenter Phase III TrialMetastasic NSCLC · Assistance Publique - Hôpitaux de Paris	Phase 3	Not yet recruiting	Nov 4, 2026
Assessment of The Potential Therapeutic Effects of Trimetazidine on Aluminium Phosphide-Induced Cardiotoxicity as an Adjuvant Therapy: A Pilot StudyAluminum Phosphide Poisoning · Ain Shams University	Phase 3	Recruiting	Nov 4, 2026
Asprosin and miRNA Expression in Young Women With Metabolic SyndromeMetabolic Syndrome, Insulin Resistance · University of Applied Sciences in Nowy Targ	—	Recruiting	Nov 4, 2026
Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer SurvivorsChronic Pain, Neuropathic Pain · Instituto de investigación e innovación biomédica de Cádiz	Not applicable	Not yet recruiting	Nov 3, 2026
MK-2870-U01 Substudy 1: A Clinical Trial of Sacituzumab Tirumotecan to Treat Prostate Cancer (MK-2870-01A)Metastatic Castration-resistant Prostate Cancer · Merck Sharp & Dohme LLC	Phase 1 / Phase 2	Not yet recruiting	Nov 2, 2026

Applications

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


Aug 5, 1952	HydrocortoneNDA 8506 · TYPE 2/4	Merck	7	Discontinued
Dec 15, 1952	CortefNDA 8697 · New formulation or manufacturer	Pharmacia And Upjohn	10	Marketed
Dec 3, 1953	CortrilNDA 9127 · New formulation or manufacturer	Pfizer	0	Discontinued
Jan 19, 1955	HydrocortisoneNDA 9659 · New formulation or manufacturer	Panray	1	Discontinued
Jan 12, 1966	CortenemaNDA 16199 · New dosage form	Ani Pharms	14	Marketed
Dec 22, 1971	TexacortANDA 80425	Mission Pharma	6	Discontinued
Dec 22, 1971	CetacortANDA 80426	Bausch	7	Discontinued
Apr 4, 1972	NutracortANDA 80442	Bausch	13	Discontinued
Apr 26, 1972	NutracortANDA 80443	Dow Pharm	10	Discontinued
May 1, 1972	HydrocortisoneANDA 80568	Ferrante	0	Discontinued
May 24, 1972	CortrilNDA 9176 · New dosage form	Pfizer Global	2	Discontinued
Jun 15, 1972	HydrocortisoneANDA 80355	Watson Labs	0	Discontinued
Sep 15, 1972	HydrocortisoneANDA 80400	Teva	8	Discontinued
Sep 25, 1972	HytoneANDA 80473	Valeant Intl	11	Discontinued
Sep 26, 1972	HytoneANDA 80474	Dermik Labs	1	Discontinued
Sep 27, 1972	HytoneANDA 80472	Valeant Intl	11	Discontinued
Feb 28, 1973	Ala-CortANDA 83201	Crown Labs	1	Discontinued
Feb 28, 1973	Ala-ScalpANDA 83231	Legacy	6	Marketed
Mar 9, 1973	HydrocortisoneANDA 83140	Nexgen Pharma Inc	0	Discontinued
Mar 9, 1973	Ala-CortANDA 80706	Crown Labs	6	Marketed
Mar 20, 1973	HcANDA 80481	C And M Pharma	0	Discontinued
Mar 20, 1973	HcANDA 80482	C And M Pharma	1	Discontinued
Mar 20, 1973	Hi-CorANDA 80483	C And M Pharma	3	Discontinued
Apr 26, 1973	Proctocort, DermacortANDA 83011	Monarch Pharms	1	Discontinued
May 18, 1973	HydrocortisoneANDA 80496	Whiteworth Town Plsn	1	Discontinued
Jun 18, 1973	HydrocortisoneANDA 83365	Hikma	31	Discontinued
Jul 18, 1973	HydrocortisoneANDA 80344	Whiteworth Town Plsn	3	Discontinued
Mar 6, 1974	HydrocortisoneANDA 83999	Barr	0	Discontinued
May 31, 1974	HydrocortisoneANDA 80642	Sandoz	0	Discontinued
Apr 16, 1975	HydrocortisoneANDA 80692	Fougera Pharms	11	Marketed
Jan 6, 1976	NutracortANDA 84698	Healthpoint	1	Discontinued
Apr 30, 1976	HydrocortisoneANDA 80693	Fougera Pharms Inc	8	Marketed
May 7, 1976	HydrocortisoneANDA 85070	Chartwell Molecular	1	Discontinued
Nov 30, 1977	HydrocortisoneANDA 85027	Padagis US	9	Marketed
Apr 26, 1978	HydrocortisoneANDA 86080	Ambix	0	Discontinued
Apr 26, 1978	HydrocortisoneANDA 86271	Ambix	0	Discontinued
Apr 26, 1978	HydrocortisoneANDA 86272	Ambix	0	Discontinued
May 9, 1978	Hydro-RxANDA 85982	X Gen Pharms	3	Discontinued
May 11, 1978	HydrocortisoneANDA 86079	Ambix	1	Discontinued
Jun 5, 1978	HydrocortisoneANDA 85282	Mericon	4	Discontinued
Jul 24, 1978	HydrocortisoneANDA 86257	Sun Pharma Canada	12	Discontinued
Jul 24, 1978	HydrocortisoneANDA 86155	Taro	22	Discontinued
Nov 6, 1978	HydrocortisoneANDA 85733	Ivax Pharms	0	Discontinued
Feb 4, 1981	ActicortANDA 86535	Baker Norton	1	Discontinued
Jun 23, 1981	SynacortANDA 87457	Bausch	4	Discontinued
Jun 23, 1981	SynacortANDA 87459	Bausch	1	Discontinued
Jun 23, 1981	SynacortANDA 87458	Bausch	5	Discontinued
Mar 29, 1982	H-CortANDA 87834	Torch	0	Discontinued
Jun 7, 1982	HydrocortisoneANDA 87315	Alpharma US Pharms	0	Discontinued
Jun 7, 1982	HydrocortisoneANDA 87317	Alpharma US Pharms	3	Discontinued
Aug 24, 1982	NutracortANDA 87644	Dow Pharm	9	Discontinued
Oct 13, 1982	HydrocortisoneANDA 87796	Actavis Mid Atlantic	13	Discontinued
Dec 3, 1982	Balneol-HcANDA 88041	Solvay	0	Discontinued
Apr 8, 1983	HydrocortisoneANDA 88082	Paddock LLC	5	Discontinued
Apr 21, 1983	HydrocortisoneANDA 85025	Padagis US	6	Marketed
May 3, 1983	HydrocortisoneANDA 87795	Actavis Mid Atlantic	19	Marketed
Sep 27, 1983	HydrocortisoneANDA 88039	Usl Pharma	0	Discontinued
Sep 27, 1983	HydrocortisoneANDA 88061	Usl Pharma	0	Discontinued
Oct 3, 1983	GlycortANDA 87489	Heran	0	Discontinued
Jun 6, 1984	PenecortANDA 88214	Allergan Herbert	6	Discontinued
Jun 6, 1984	PenecortANDA 88216	Allergan Herbert	5	Discontinued
Jun 6, 1984	Anusol HcANDA 88250	Salix Pharms	8	Discontinued
Nov 9, 1984	HydrocortisoneANDA 88799	Taro	14	Marketed
Sep 6, 1985	Hydrocortisone In AbsorbaseANDA 88138	Pharmobedient	3	Marketed
Nov 25, 1985	Stie-CortANDA 89066	Padagis US	8	Discontinued
Nov 26, 1985	Stie-CortANDA 89074	Padagis US	12	Marketed
Feb 12, 1986	HydrocortisoneANDA 89024	Taro	3	Discontinued
Dec 16, 1986	HydrocortisoneANDA 89414	Fougera Pharms Inc	4	Marketed
Feb 9, 1987	HydrocortisoneANDA 88842	Pharmaderm	0	Discontinued
Jan 25, 1988	Beta-HcANDA 89495	Beta Dermac	0	Discontinued
Mar 10, 1988	HydrocortisoneANDA 89682	Actavis Mid Atlantic	19	Discontinued
Mar 10, 1988	HydrocortisoneANDA 89704	Naska	0	Discontinued
Mar 10, 1988	HydrocortisoneANDA 89706	Naska	0	Discontinued
Apr 4, 1988	Nogenic HcANDA 87427	Ivax Pharms	3	Discontinued
Apr 25, 1988	HydrocortisoneANDA 89705	Naska	1	Discontinued
Feb 17, 1989	HydrocortisoneANDA 89273	Topiderm	0	Discontinued
Apr 17, 1992	TexacortANDA 81271	Mission Pharma	0	Marketed
May 28, 1993	HydrocortisoneANDA 81203	Fougera Pharms Inc	7	Marketed
May 27, 1994	HydrocortisoneANDA 74171	Teva Pharms	15	Discontinued
Jul 23, 1999	HydrocortisoneANDA 40247	Sun Pharma Canada	1	Discontinued
Dec 3, 1999	ColocortANDA 75172	Chartwell	3	Marketed
Jul 25, 2000	HydrocortisoneANDA 40351	Fougera Pharms	1	Discontinued
Dec 29, 2000	HydrocortisoneANDA 40310	Sun Pharma Canada	0	Discontinued
Jul 30, 2003	HydrocortisoneANDA 40417	Chartwell Molecular	0	Discontinued
Mar 12, 2004	HydrocortisoneANDA 40503	Chartwell Molecular	0	Discontinued
Mar 30, 2007	HydrocortisoneANDA 40646	Impax Labs Inc	4	Marketed
Jul 16, 2007	HydrocortisoneANDA 40761	Strides Pharma Intl	3	Discontinued
Aug 20, 2010	HydrocortisoneANDA 40879	Rising	0	Marketed
Apr 27, 2017	HydrocortisoneANDA 207029	Strides Pharma	3	Marketed
Jul 23, 2018	HydrocortisoneANDA 203810	Encube	0	Marketed
Jul 27, 2018	HydrocortisoneANDA 203804	Encube	0	Discontinued
Sep 29, 2020	Alkindi SprinkleNDA 213876 · New dosage form	Eton	3	Marketed
Jul 17, 2023	HydrocortisoneANDA 214649	Aurobindo Pharma Ltd	2	Marketed
Nov 25, 2024	HydrocortisoneANDA 217160	Adaptis	0	Marketed
May 2, 2025	HydrocortisoneANDA 217881	Novitium Pharma	0	Marketed
May 28, 2025	KhindiviNDA 218980 · New dosage form	Eton	0	Marketed
Feb 25, 2026	HydrocortisoneANDA 220329	Appco	0	Marketed
Jul 16, 2026	HydrocortisoneANDA 218298	Rising	0	Marketed
—	Cort-DomeNDA 9585	Bayer Pharms	0	Discontinued
—	CortrilNDA 9796	Pfipharmecs	0	Discontinued
—	CortefNDA 9864	Pharmacia And Upjohn	0	Discontinued
—	Cort-DomeNDA 9895	Bayer Pharms	0	Discontinued
—	HydrocortisoneANDA 84969	Perrigo New York	0	Discontinued
—	HydrocortisoneANDA 84970	Perrigo New York	0	Discontinued
—	HydrocortisoneANDA 85026	Perrigo New York	0	Discontinued
—	HydrocortisoneANDA 80395	Purepac Pharm	0	Discontinued
—	Hc #1, Hc #4ANDA 80438	Bayer Pharms	0	Discontinued
—	HydrocortisoneANDA 80452	Everylife	0	Discontinued
—	HydrocortisoneANDA 80456	Ingram Pharm	0	Discontinued
—	EldecortANDA 80459	Valeant Pharm Intl	3	Discontinued
—	HydrocortisoneANDA 80489	Altana	3	Discontinued
—	HydrocortisoneANDA 80624	Elkins Sinn	0	Discontinued
—	HydrocortisoneANDA 80732	Inwood Labs	0	Discontinued
—	HydrocortisoneANDA 80781	Impax Labs	0	Discontinued
—	HydrocortisoneANDA 80848	Altana	0	Discontinued
—	EpicortANDA 83219	Bluline	0	Discontinued
—	EldecortANDA 84055	Valeant Pharm Intl	0	Discontinued
—	HydrocortisoneANDA 84059	G And W Labs	0	Discontinued
—	HydrocortisoneANDA 84243	Parke Davis	0	Discontinued
—	HydrocortisoneANDA 84247	Purepac Pharm	0	Discontinued
—	DermacortANDA 84573	Solvay	0	Discontinued
—	HydrocortisoneANDA 85028	Perrigo New York	0	Discontinued
—	HydrocortisoneANDA 85191	Teva	0	Discontinued
—	HydrocortisoneANDA 85527	Syosset	0	Discontinued
—	HydrocortisoneANDA 85662	Perrigo New York	0	Discontinued
—	HydrocortisoneANDA 85663	Perrigo New York	0	Discontinued
—	Aeroseb-HcANDA 85805	Allergan Herbert	0	Discontinued
—	HydrocortisoneANDA 86154	Taro	4	Discontinued
—	HydrocortisoneANDA 86170	Stiefel	0	Discontinued
—	HydrocortisoneANDA 86256	Taro	2	Discontinued
—	DermacortANDA 86462	Solvay	0	Discontinued
—	H-CortANDA 86823	Pharm Assoc	0	Discontinued
—	H-CortANDA 86824	Pharm Assoc	0	Discontinued
—	FlexicortANDA 87136	Westwood Squibb	0	Discontinued
—	HydrocortisoneANDA 87838	Pharmafair	0	Discontinued
—	HydrocortisoneANDA 88027	Usl Pharma	0	Discontinued
—	HydrocortisoneANDA 88029	Usl Pharma	0	Discontinued
—	PenecortANDA 88215	Allergan Herbert	0	Discontinued
—	PenecortANDA 88217	Allergan Herbert	0	Discontinued
—	HydrocortisoneANDA 88539	Roxane	0	Discontinued
—	HydrocortisoneANDA 88845	Pharmaderm	0	Discontinued
—	HydrocortisoneANDA 89413	Pharmaderm	0	Discontinued
—	HydrocortisoneANDA 89754	Alpharma US Pharms	0	Discontinued

Show all 143

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