Hydroxyzine Hydrochloride

Sold as Atarax, Vistaril. Every FDA application for this active ingredient: 3 branded and 107 generic.

As of Nov 15, 2026, FDA lists 110 applications for Hydroxyzine Hydrochloride (sold as Atarax, Vistaril), first approved Apr 12, 1956, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 12, 1956
Applications: 110
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $83.5M

Medicare Spending

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


Hydroxyzine HCl	Part D	$83.5M	+13%	1,561,411
Hydroxyzine HCL	Part B	$3K	-60%	122

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

HYDROXYZINE 10 MG/5 ML SOLN: $0.112 per MLGeneric · -22% in a year
HYDROXYZINE 10 MG/5 ML SYRUP: $0.112 per MLGeneric · -22% in a year
HYDROXYZINE HCL 10 MG TABLET: $0.029 per unitGeneric · -9% in a year
HYDROXYZINE HCL 25 MG TABLET: $0.032 per unitGeneric · -9% in a year
HYDROXYZINE HCL 50 MG TABLET: $0.054 per unitGeneric · -18% in a year

Clinical Trials

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


DV Plus Toripalimab With Cetirizine and Mecobalamin Pretreatment in Patients With Locally Advanced Unresectable or Metastatic Bladder CancerBladder Cancer · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 1	Not yet recruiting	Oct 1, 2026
Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot ProjectMultiple Sclerosis · University of Miami	Phase 3	Not yet recruiting	Mar 16, 2026
Comparing Standard-Dose and High-Dose Cetirizine for Acute UrticariaAcute Urticaria · University of Phayao	Not applicable	Recruiting	Nov 19, 2025
Investigating Pre-Procedural Anxiety and Effect of Analgesia on Intrauterine Device Placement and Endometrial BiopsyAnxiety, Pain · The University of Texas Health Science Center, Houston	Phase 2	Not yet recruiting	Jun 22, 2025
The Treatment of Moderate to Severe Allergic Rhinitis With Electroacupuncture Combined With Microneedle KnifeAllergic Rhinitis (Disorder), Electroacupuncture · Pengfei Qiu	Not applicable	Recruiting	Mar 21, 2025
Phase III Clinical Study of Cetirizine Hydrochloride Injection in Treatment of Acute UrticariaAcute Urticaria · Shandong New Time Pharmaceutical Co., LTD	Phase 3	Recruiting	Feb 11, 2025
The Impact of Airway Allergic Diseases on Children's and Parents' Quality of LifePediatric Asthma, Rhinitis, Allergic · Wenjing Zhou	—	Recruiting	Aug 2, 2024
Efficacy of Hydroxyzine for Patients With Panic DisorderPanic Disorder · Sultan Qaboos University	Phase 4	Not yet recruiting	Feb 21, 2023

Applications

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


Apr 12, 1956	AtaraxNDA 10392 · New molecular entity	Pfizer	8	Discontinued
May 31, 1956	AtaraxNDA 10485 · New dosage form	Roerig	3	Discontinued
Sep 18, 1957	VistarilNDA 11111 · New dosage form	Pfizer	3	Discontinued
Aug 24, 1979	Hydroxyzine Hydrochloride, HydroxyzineANDA 85551	Baxter Hlthcare	15	Discontinued
Sep 5, 1979	Hydroxyzine HydrochlorideANDA 86821	Hospira	5	Discontinued
Oct 5, 1979	Hydroxyzine HydrochlorideANDA 85779	Dr Reddys	18	Discontinued
Oct 5, 1979	Hydroxyzine HydrochlorideANDA 85778	Watson Labs	21	Discontinued
Jun 27, 1980	OrgatraxANDA 87014	Organon USA Inc	4	Discontinued
Jul 17, 1980	Hydroxyzine HydrochlorideANDA 86880	Rising	23	Discontinued
Mar 20, 1981	Hydroxyzine HydrochlorideANDA 86827	Watson Labs	1	Discontinued
Mar 20, 1981	Hydroxyzine HydrochlorideANDA 86829	Watson Labs	1	Discontinued
Apr 3, 1981	Hydroxyzine HydrochlorideANDA 87216	Ivax Pharms	0	Discontinued
Apr 3, 1981	Hydroxyzine HydrochlorideANDA 87410	Ivax Pharms	0	Discontinued
Apr 3, 1981	Hydroxyzine HydrochlorideANDA 87411	Ivax Pharms	0	Discontinued
May 15, 1981	Hydroxyzine HydrochlorideANDA 86836	Watson Labs	1	Discontinued
Jun 15, 1981	Hydroxyzine HydrochlorideANDA 87416	Hospira	7	Discontinued
Jun 15, 1981	Hydroxyzine HydrochlorideANDA 87546	Hospira	7	Discontinued
Jul 28, 1981	Hydroxyzine HydrochlorideANDA 87274	Watson Labs	0	Discontinued
Aug 11, 1981	Hydroxyzine HydrochlorideANDA 87329	Fresenius Kabi USA	14	Discontinued
Aug 27, 1981	Hydroxyzine HydrochlorideANDA 87408	Am Regent	12	Marketed
Jan 22, 1982	Hydroxyzine HydrochlorideANDA 87602	Strides Pharma Intl	15	Discontinued
Jan 22, 1982	Hydroxyzine HydrochlorideANDA 87603	Strides Pharma Intl	14	Discontinued
Jan 22, 1982	Hydroxyzine HydrochlorideANDA 87604	Strides Pharma Intl	14	Discontinued
Apr 12, 1982	Hydroxyzine HydrochlorideANDA 87294	Chartwell Rx	20	Marketed
Jun 23, 1982	Hydroxyzine HydrochlorideANDA 87819	Kv Pharm	2	Discontinued
Jun 23, 1982	Hydroxyzine HydrochlorideANDA 87820	Kv Pharm	2	Discontinued
Jun 23, 1982	Hydroxyzine HydrochlorideANDA 87821	Kv Pharm	3	Discontinued
Jun 23, 1982	Hydroxyzine HydrochlorideANDA 87822	Kv Pharm	3	Discontinued
Dec 20, 1982	Hydroxyzine HydrochlorideANDA 87871	Aurobindo Pharma Ltd	13	Marketed
Mar 31, 1983	Hydroxyzine HydrochlorideANDA 88185	Fresenius Kabi USA	10	Discontinued
Mar 31, 1983	Hydroxyzine HydrochlorideANDA 88184	Fresenius Kabi USA	5	Discontinued
Apr 18, 1983	Hydroxyzine HydrochlorideANDA 87857	Mutual Pharm	9	Discontinued
Apr 18, 1983	Hydroxyzine HydrochlorideANDA 87860	Mutual Pharm	10	Discontinued
Apr 18, 1983	Hydroxyzine HydrochlorideANDA 87862	Sun Pharm Industries	11	Discontinued
Sep 15, 1983	Hydroxyzine HydrochlorideANDA 88348	Watson Labs	25	Discontinued
Sep 15, 1983	Hydroxyzine HydrochlorideANDA 88349	Watson Labs	25	Discontinued
Sep 15, 1983	Hydroxyzine HydrochlorideANDA 88350	Watson Labs	20	Discontinued
Nov 15, 1983	Hydroxyzine HydrochlorideANDA 88409	Mutual Pharm	9	Discontinued
Dec 5, 1984	Hydroxyzine HydrochlorideANDA 88794	Superpharm	2	Discontinued
Dec 5, 1984	Hydroxyzine HydrochlorideANDA 88795	Superpharm	2	Discontinued
Dec 5, 1984	Hydroxyzine HydrochlorideANDA 88796	Superpharm	1	Discontinued
Jan 10, 1986	Hydroxyzine HydrochlorideANDA 88617	Pliva	16	Marketed
Jan 10, 1986	Hydroxyzine HydrochlorideANDA 88619	Pliva	16	Marketed
Jan 10, 1986	Hydroxyzine HydrochlorideANDA 88618	Pliva	16	Marketed
May 19, 1986	Hydroxyzine HydrochlorideANDA 89382	Sun Pharm Industries	17	Discontinued
May 19, 1986	Hydroxyzine HydrochlorideANDA 89383	Sun Pharm Industries	16	Discontinued
May 19, 1986	Hydroxyzine HydrochlorideANDA 89381	Sun Pharm Industries	16	Discontinued
May 2, 1988	Hydroxyzine HydrochlorideANDA 89117	Halsey	0	Discontinued
Mar 18, 1994	Hydroxyzine HydrochlorideANDA 81149	Watson Labs	10	Discontinued
Mar 18, 1994	Hydroxyzine HydrochlorideANDA 81150	Watson Labs	10	Discontinued
Mar 18, 1994	Hydroxyzine HydrochlorideANDA 81151	Watson Labs	11	Discontinued
Oct 28, 1994	Hydroxyzine HydrochlorideANDA 40010	Hikma	5	Discontinued
Sep 25, 1995	Hydroxyzine HydrochlorideANDA 81054	Pliva	0	Discontinued
Apr 10, 2002	Hydroxyzine HydrochlorideANDA 40391	Pai Holdings Pharm	4	Marketed
Jul 22, 2004	Hydroxyzine HydrochlorideANDA 40559	Able	0	Discontinued
Jul 22, 2004	Hydroxyzine HydrochlorideANDA 40562	Able	0	Discontinued
Jul 22, 2004	Hydroxyzine HydrochlorideANDA 40563	Able	0	Discontinued
Dec 28, 2004	Hydroxyzine HydrochlorideANDA 40604	Epic Pharma LLC	3	Marketed
May 27, 2005	Hydroxyzine HydrochlorideANDA 40580	Prinston	5	Marketed
Mar 20, 2007	Hydroxyzine HydrochlorideANDA 40786	Kvk Tech	3	Marketed
Mar 12, 2008	Hydroxyzine HydrochlorideANDA 40812	Somerset Theraps LLC	3	Discontinued
Mar 31, 2008	Hydroxyzine HydrochlorideANDA 40840	Northstar Hlthcare	6	Marketed
Mar 31, 2008	Hydroxyzine HydrochlorideANDA 40841	Northstar Hlthcare	4	Marketed
Mar 31, 2008	Hydroxyzine HydrochlorideANDA 40842	Northstar Hlthcare	4	Marketed
May 29, 2008	Hydroxyzine HydrochlorideANDA 40805	Hetero Labs Ltd Iii	3	Marketed
Jun 10, 2008	Hydroxyzine HydrochlorideANDA 40899	Sun Pharm Inds Inc	3	Discontinued
Jun 30, 2008	Hydroxyzine HydrochlorideANDA 40804	Chartwell Rx	3	Marketed
Sep 24, 2008	Hydroxyzine HydrochlorideANDA 40808	Amneal Pharm	3	Discontinued
Jun 7, 2010	Hydroxyzine HydrochlorideANDA 91176	Rising	4	Discontinued
Aug 21, 2013	Hydroxyzine HydrochlorideANDA 201674	Lannett Co Inc	3	Marketed
Aug 20, 2014	Hydroxyzine HydrochlorideANDA 204279	Heritage	3	Marketed
Mar 29, 2017	Hydroxyzine HydrochlorideANDA 207121	Nuvo Pharms Inc	0	Marketed
Feb 26, 2019	Hydroxyzine HydrochlorideANDA 210634	Pharmazone	0	Marketed
Aug 17, 2023	Hydroxyzine HydrochlorideANDA 217652	Graviti Pharms	1	Marketed
Apr 28, 2025	Hydroxyzine HydrochlorideANDA 219289	Bionpharma	0	Marketed
Dec 16, 2025	Hydroxyzine HydrochlorideANDA 219648	Novitium Pharma	0	Marketed
Jun 11, 2026	Hydroxyzine HydrochlorideANDA 220271	Sciegen Pharms	0	Marketed
Sep 11, 2026	Hydroxyzine HydrochlorideANDA 219561	Rubicon Research	0	Marketed
—	Hydroxyzine HydrochlorideANDA 88540	Quantum Pharmics	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 85247	Sandoz	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 86258	Wyeth Ayerst	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 86822	Solopak	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 89121	Usl Pharma	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 87245	Sandoz	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 87246	Sandoz	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 87273	Altana	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 87310	Solopak	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 89122	Usl Pharma	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 87591	Solopak	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 87592	Smith And Nephew	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 87593	Solopak	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 87595	Solopak	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 87596	Solopak	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 87730	Kv Pharm	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 89123	Usl Pharma	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 88120	Purepac Pharm	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 88121	Purepac Pharm	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 88122	Purepac Pharm	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 88529	Quantum Pharmics	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 88551	Quantum Pharmics	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 88785	Alpharma US Pharms	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 88862	Pharmafair	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 88881	Pharmafair	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 89071	Actavis Elizabeth	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 89072	Actavis Elizabeth	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 89073	Actavis Elizabeth	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 89106	Pharmafair	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 89107	Pharmafair	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 89366	Halsey	0	Discontinued
—	Hydroxyzine HydrochlorideANDA 89396	Halsey	0	Discontinued

Show all 110

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