Prescription medicine
Hydralazine First approved as Apresoline
Hydralazine (Apresoline) is a prescription medicine with an FDA approval on record since 1953. FDA's NDC Directory lists it from 43 generic labelers, and pharmacies paid $0.0357 per hydralazine 25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the hydralazine FDA label on DailyMed (effective April 3, 2026, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the NDA 8303 record on Drugs@FDA; every hydralazine label on DailyMed.
Highlights of the record
FDA label of April 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageEssential hypertension, alone or as an adjunct.
Forms and strengths
- 10 mg
- 25 mg
- 50 mg
- 100 mg
- 20 mg/ml
Tablet; injection; film-coated tablet; injection (solution).
On the market
- Earliest approval on file
- January 15, 1953 Apresoline, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 62 first August 5, 1974; 19 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 43 of which 43 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0357 per tablet Hydralazine 25 mg tablet
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 12 since 2013 0 Class I among all firms' recalls; latest January 24, 2025; 5 more by firms not listed as its makers
- FAERS reports
- 2,614 through July 30, 2026
What is hydralazine used for?
From the label: indications and usageEssential hypertension, alone or as an adjunct.
FDA pharmacologic class: Arteriolar Vasodilator.
Source: FDA drug label (Hydralazine Hydrochloride), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective April 3, 2026 (SPL set 669532c9-ba15-4f4b-95a8-13782deb3521), via openFDA; the full label on DailyMed
Is there a generic for hydralazine (Apresoline)?
The FDA approved the first generic hydralazine on August 5, 1974. 62 generic applications are approved; 19 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists hydralazine from 43 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1953 earliest approval on file
- 1974 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for hydralazine (Apresoline)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0357 per Hydralazine 25 mg tablet, down 4% from $0.0371 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Hydralazine 25 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Hydralazine 10 mg tablet | Generic | $0.027 per tablet | $0.810 | -10% |
| Hydralazine 100 mg tablet | Generic | $0.0717 per tablet | $2.15 | -9% |
| Hydralazine 25 mg tablet | Generic | $0.0357 per tablet | $1.07 | -4% |
| Hydralazine 50 mg tablet | Generic | $0.0445 per tablet | $1.34 | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is hydralazine in shortage?
No hydralazine presentation is listed as limited or unavailable in the FDA Drug Shortage Database (read October 8, 2026); it keeps 1 current entry listed as available (updated August 27, 2026). ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Furosemide, Injection, 10 mg/mL, 2 mL (NDC 71288-205-03) | Meitheal Pharmaceuticals, Inc. | Current | August 27, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has hydralazine been recalled?
The FDA's Enforcement Report lists 17 recalls naming hydralazine since 2013: 0 Class I (the most serious), 13 Class II, 4 Class III; 3 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of hydralazine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 24, 2025 | Class II | SKY PACKAGING | Failed Impurities/Degradation Specifications |
| November 5, 2024 | Class III | The Harvard Drug Group LLC dba Major Pharmaceuticals and … | Failed Impurities/Degradation Specifications; during routine stability testing for impurities. |
| February 9, 2024 | Class II | The Harvard Drug Group LLC dba Major Pharmaceuticals and … | an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a … |
| February 1, 2024 | Class III | Amerisource Health Services LLC not a listed maker | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month … |
| September 1, 2023 | Class III | Amerisource Health Services LLC | Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point. |
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| February 24, 2022 | Class II | The Harvard Drug Group | Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities. |
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydralazine label say about other medicines?
The hydralazine label names no other medicine on this site. The labels of 11 other medicines name hydralazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name hydralazine
Source: FDA drug label (Hydralazine Hydrochloride), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective April 3, 2026 (SPL set 669532c9-ba15-4f4b-95a8-13782deb3521), via openFDA; the full label on DailyMed
What do FAERS reports show for hydralazine?
The FDA Adverse Event Reporting System holds 2,614 reports that list hydralazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 204 are coded as a death and 1,164 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other arteriolar vasodilators
- the pharmacologic class, with prices and generics
- Hydralazine side effects
- the label's list beside FAERS reports
- Hydralazine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other