Hydralazine Hydrochloride

Sold as Apresoline. Every FDA application for this active ingredient: 1 branded and 86 generic.

As of Nov 15, 2026, FDA lists 87 applications for Hydralazine Hydrochloride (sold as Apresoline), first approved Jan 15, 1953, with 0 new uses approved and 0 published complete response letters.

First approved: Jan 15, 1953
Applications: 87
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $76.7M
Shortage: Current

Medicare Spending

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


Hydralazine HCl	Part D	$76.7M	-6%	1,504,937
Hydralazine HCL	Part B	$5K	-24%	640

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

HYDRALAZINE 10 MG TABLET: $0.026 per unitGeneric · -15% in a year
HYDRALAZINE 100 MG TABLET: $0.070 per unitGeneric · -12% in a year
HYDRALAZINE 25 MG TABLET: $0.035 per unitGeneric · -6% in a year
HYDRALAZINE 50 MG TABLET: $0.044 per unitGeneric · -6% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of severe intrapartum hypertension (diastolic blood pressure greater than or equal to 110 or systolic blood…Bioniche Pharma USA LLC · designated Apr 9, 2004

Shortages

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

Shortage	Status	First posted	Updated
Furosemide Injection	Current	Apr 7, 2020	Nov 9, 2026

Clinical Trials

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


Furosemide vs Placebo in Severe Preeclampsia PostpartumSevere Preeclampsia · Universidad Nacional Autonoma de Honduras	Phase 2	Not yet recruiting	Jun 15, 2026
Efficacy and Safety of Qishen Yiqi Dropping Pills in Patients With Severe Pulmonary HypertensionIdiopathic Pulmonary Hypertension · Guangdong Provincial People's Hospital	Not applicable	Recruiting	May 22, 2026
Comparison of Post-Craniotomy Blood Pressure TargetsIntracranial Hemorrhage, Hypertensive, Craniotomy Tumor Removal Surgery · Vanderbilt University Medical Center	Not applicable	Enrolling by invitation	Jul 30, 2025
Diuretics vs. Afterload Reduction for Treatment of HeartLogic AlertsHeart Failure, Congestive · Heart Center Research, LLC	Phase 4	Recruiting	Jan 23, 2024
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension · Duke University	—	Recruiting	Feb 20, 2020
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) StudyStage D Heart Failure · The Cleveland Clinic	Phase 4	Recruiting	Dec 10, 2019
Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart FailureEnd-stage Heart Failure · Vastra Gotaland Region	Not applicable	Active, not recruiting	Oct 30, 2015
Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant HypertensionHigh Blood Pressure · CVRx, Inc.	Not applicable	Active, not recruiting	Nov 16, 2011

Applications

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


Jan 15, 1953	ApresolineNDA 8303 · New molecular entity	Novartis	40	Discontinued
Aug 5, 1974	Hydralazine HydrochlorideANDA 84106	Mutual Pharm	12	Discontinued
Nov 8, 1974	Hydralazine HydrochlorideANDA 84107	Mutual Pharm	9	Discontinued
Sep 8, 1975	Hydralazine HydrochlorideANDA 84443	Ivax Sub Teva Pharms	1	Discontinued
Sep 12, 1975	Hydralazine HydrochlorideANDA 84581	Ivax Sub Teva Pharms	0	Discontinued
Feb 19, 1976	Hydralazine HydrochlorideANDA 84437	Ivax Sub Teva Pharms	1	Discontinued
Feb 19, 1976	Hydralazine HydrochlorideANDA 84469	Ivax Sub Teva Pharms	1	Discontinued
Aug 5, 1976	Hydralazine HydrochlorideANDA 83241	Upsher Smith Labs	9	Discontinued
Aug 5, 1976	Hydralazine HydrochlorideANDA 83560	Upsher Smith Labs	11	Discontinued
Aug 5, 1976	Hydralazine HydrochlorideANDA 83561	Upsher Smith Labs	10	Discontinued
Nov 23, 1976	Hydralazine HydrochlorideANDA 84503	Watson Labs	13	Discontinued
Nov 23, 1976	Hydralazine HydrochlorideANDA 84504	Watson Labs	8	Discontinued
Apr 14, 1977	Hydralazine HydrochlorideANDA 85532	Watson Labs	1	Discontinued
Apr 14, 1977	Hydralazine HydrochlorideANDA 85533	Watson Labs	1	Discontinued
Oct 23, 1978	Hydralazine HydrochlorideANDA 86243	Heritage Pharms Inc	2	Discontinued
Oct 23, 1978	Hydralazine HydrochlorideANDA 86242	Heritage	12	Discontinued
Feb 27, 1980	Hydralazine HydrochlorideANDA 86961	Strides Pharma Intl	9	Discontinued
Feb 27, 1980	Hydralazine HydrochlorideANDA 86962	Strides Pharma Intl	9	Discontinued
Mar 29, 1982	Hydralazine HydrochlorideANDA 87751	Usl Pharma	1	Discontinued
Mar 29, 1982	Hydralazine HydrochlorideANDA 87780	Usl Pharma	1	Discontinued
May 7, 1982	Hydralazine HydrochlorideANDA 87908	Vangard	4	Discontinued
Oct 5, 1982	Hydralazine HydrochlorideANDA 87836	Strides Pharma Intl	5	Discontinued
Sep 27, 1983	Hydralazine HydrochlorideANDA 88391	Strides Pharma Intl	4	Discontinued
May 1, 1984	Hydralazine HydrochlorideANDA 88467	Pliva	15	Marketed
May 1, 1984	Hydralazine HydrochlorideANDA 88468	Pliva	16	Marketed
Aug 28, 1984	Hydralazine HydrochlorideANDA 88787	Superpharm	0	Discontinued
Aug 28, 1984	Hydralazine HydrochlorideANDA 88788	Superpharm	0	Discontinued
Aug 28, 1984	Hydralazine HydrochlorideANDA 88789	Superpharm	0	Discontinued
Feb 26, 1985	Hydralazine HydrochlorideANDA 88846	Chartwell Rx	7	Discontinued
Feb 26, 1985	Hydralazine HydrochlorideANDA 88848	Chartwell Rx	7	Discontinued
Feb 26, 1985	Hydralazine HydrochlorideANDA 88847	Chartwell Rx	7	Discontinued
Feb 26, 1985	Hydralazine HydrochlorideANDA 88849	Chartwell Rx	7	Discontinued
Apr 11, 1985	Hydralazine HydrochlorideANDA 88728	Mutual Pharm	7	Discontinued
Apr 11, 1985	Hydralazine HydrochlorideANDA 88729	Tp Anda Holdings	7	Discontinued
Dec 18, 1985	Hydralazine HydrochlorideANDA 89098	Pliva	9	Marketed
Dec 18, 1985	Hydralazine HydrochlorideANDA 89097	Pliva	10	Marketed
May 5, 1986	Hydralazine HydrochlorideANDA 89258	Tp Anda Holdings	10	Discontinued
May 5, 1986	Hydralazine HydrochlorideANDA 89259	Tp Anda Holdings	9	Discontinued
Jul 25, 1986	Hydralazine HydrochlorideANDA 89359	Tp Anda Holdings	10	Discontinued
Sep 16, 1994	Hydralazine HydrochlorideANDA 85088	Upsher Smith Labs	8	Discontinued
Jun 30, 1997	Hydralazine HydrochlorideANDA 40136	Am Regent	2	Marketed
Feb 23, 2000	Hydralazine HydrochlorideANDA 40373	Teva Parenteral	0	Discontinued
Mar 13, 2001	Hydralazine HydrochlorideANDA 40388	Fresenius Kabi USA	1	Marketed
Sep 12, 2008	Hydralazine HydrochlorideANDA 40901	Hetero Labs Ltd Iii	1	Marketed
Dec 15, 2008	Hydralazine HydrochlorideANDA 90255	Invagen Pharms	0	Discontinued
Apr 21, 2009	Hydralazine HydrochlorideANDA 40730	Rising	2	Marketed
May 29, 2009	Hydralazine HydrochlorideANDA 90527	Glenmark Pharms Ltd	1	Marketed
Feb 26, 2010	Hydralazine HydrochlorideANDA 40858	Heritage Pharms Inc	1	Marketed
Dec 8, 2010	Hydralazine HydrochlorideANDA 90413	Pharmobedient	0	Discontinued
Dec 7, 2012	Hydralazine HydrochlorideANDA 200737	Alkem Labs Ltd	0	Marketed
Mar 4, 2013	Hydralazine HydrochlorideANDA 91679	Actavis Grp Ptc	0	Discontinued
Mar 28, 2013	Hydralazine HydrochlorideANDA 202938	Navinta LLC	0	Marketed
May 3, 2013	Hydralazine HydrochlorideANDA 200770	Strides Pharma	0	Marketed
Sep 18, 2014	Hydralazine HydrochlorideANDA 203845	Cadila Pharms Ltd	2	Marketed
Jun 29, 2015	Hydralazine HydrochlorideANDA 203110	Pharmobedient	0	Discontinued
Apr 28, 2016	Hydralazine HydrochlorideANDA 204680	Pharmobedient	0	Discontinued
May 26, 2017	Hydralazine HydrochlorideANDA 205236	Sciegen Pharms	0	Marketed
Jul 9, 2018	Hydralazine HydrochlorideANDA 209251	Rising	0	Discontinued
Dec 18, 2020	Hydralazine HydrochlorideANDA 213667	Hikma	0	Marketed
Feb 13, 2023	Hydralazine HydrochlorideANDA 215147	Eugia Pharma	0	Marketed
Aug 21, 2024	Hydralazine HydrochlorideANDA 211010	Macleods Pharms	0	Discontinued
Jun 2, 2025	Hydralazine HydrochlorideANDA 217501	Kindos	0	Marketed
Jul 17, 2025	Hydralazine HydrochlorideANDA 219797	Baxter Hlthcare Corp	0	Marketed
—	DralzineANDA 84301	Teva	0	Discontinued
—	Hydralazine HydrochlorideANDA 84922	Impax Labs	0	Discontinued
—	Hydralazine HydrochlorideANDA 84923	Impax Labs	0	Discontinued
—	Hydralazine HydrochlorideANDA 86088	Vitarine	0	Discontinued
—	Hydralazine HydrochlorideANDA 87712	Vangard	0	Discontinued
—	Hydralazine HydrochlorideANDA 88177	Purepac Pharm	0	Discontinued
—	Hydralazine HydrochlorideANDA 88178	Purepac Pharm	0	Discontinued
—	Hydralazine HydrochlorideANDA 88240	West Ward	0	Discontinued
—	Hydralazine HydrochlorideANDA 88241	West Ward	0	Discontinued
—	Hydralazine HydrochlorideANDA 88310	Ascot	0	Discontinued
—	Hydralazine HydrochlorideANDA 88311	Ascot	0	Discontinued
—	Hydralazine HydrochlorideANDA 88517	Solopak	0	Discontinued
—	Hydralazine HydrochlorideANDA 88518	Smith And Nephew	0	Discontinued
—	Hydralazine HydrochlorideANDA 88560	Actavis Elizabeth	0	Discontinued
—	Hydralazine HydrochlorideANDA 88649	Actavis Elizabeth	0	Discontinued
—	Hydralazine HydrochlorideANDA 88652	Quantum Pharmics	0	Discontinued
—	Hydralazine HydrochlorideANDA 88657	Quantum Pharmics	0	Discontinued
—	Hydralazine HydrochlorideANDA 88671	Quantum Pharmics	0	Discontinued
—	Hydralazine HydrochlorideANDA 88686	Quantum Pharmics	0	Discontinued
—	Hydralazine HydrochlorideANDA 89130	Halsey	0	Discontinued
—	Hydralazine HydrochlorideANDA 89178	Halsey	0	Discontinued
—	Hydralazine HydrochlorideANDA 89218	Halsey	0	Discontinued
—	Hydralazine HydrochlorideANDA 89222	Halsey	0	Discontinued
—	Hydralazine HydrochlorideANDA 89532	Abraxis Pharm	0	Discontinued

Show all 87

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