Quick answers
- What is Hydralazine hydrochloride used for?
- The FDA-approved label (Hydralazine Hydrochloride, Remedyrepack Inc., September 8, 2026) says: “Essential hypertension, alone or as an adjunct.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydralazine hydrochloride have a boxed warning?
- No. None of the 91 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hydralazine hydrochloride?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated August 27, 2026). Ask your pharmacist about alternatives.
- Has Hydralazine hydrochloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 8, 2017 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Hydralazine hydrochloride?
- 41 companies list prescription products of Hydralazine hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Cardinal Health 107, LLC and Remedyrepack Inc..
What Hydralazine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Essential hypertension, alone or as an adjunct.
— FDA label: Hydralazine Hydrochloride, Remedyrepack Inc., effective September 8, 2026. Read the full label on DailyMed →
The FDA has 91 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 91 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection · Tablet, film coated · Injection, solution |
|---|---|
| Route | Oral · Intramuscular · Intravenous |
| Prescription products | 141 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| hydralazine hydrochloride 10 mg tablet | Generic | $0.0260 per tablet |
| hydralazine hydrochloride 10 mg tablet, film coated | Generic | $0.0260 per tablet |
| hydralazine hydrochloride 100 mg tablet | Generic | $0.0698 per tablet |
| hydralazine hydrochloride 100 mg tablet, film coated | Generic | $0.0698 per tablet |
| hydralazine hydrochloride 25 mg tablet | Generic | $0.0350 per tablet |
| hydralazine hydrochloride 25 mg tablet, film coated | Generic | $0.0350 per tablet |
| hydralazine hydrochloride 50 mg tablet | Generic | $0.0441 per tablet |
| hydralazine hydrochloride 50 mg tablet, film coated | Generic | $0.0441 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack19 products
- Cardinal Health 107, LLC9 products
- Remedyrepack Inc.7 products
- Aphena Pharma Solutions - Tennessee, LLC6 products
- A-S Medication Solutions6 products
- Coupler LLC5 products
- Proficient Rx LP5 products
- Radha Pharmaceuticals, Inc.4 products
- Major Pharmaceuticals4 products
- Camber Pharmaceuticals, Inc.4 products
- Teva Pharmaceuticals USA, Inc.4 products
- Fresenius Kabi USA, LLC4 products
- Ascend Laboratories, LLC4 products
- Macleods Pharmaceuticals Limited4 products
- Chartwell RX, LLC4 products
- Exelan Pharmaceuticals Inc.4 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4 products
- ScieGen Pharmaceuticals, Inc.4 products
- Medical Purchasing Solutions, LLC4 products
- Strides Pharma Science Limited4 products
- Modavar Pharmaceuticals LLC3 products
- HF Acquisition Co LLC, DBA HealthFirst3 products
- Cadila Pharmaceuticals Limited3 products
- American Health Packaging3 products
- NuCare Pharmaceuticals, Inc.3 products
- Mylan Institutional Inc.3 products
- Safecor Health LLC3 products
- Eugia US LLC1 product
- Northwind Health Company, LLC1 product
- Baxter Healthcare Corporation1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Civica, Inc.1 product
- Henry Schein, Inc.1 product
- Meitheal Pharmaceuticals Inc.1 product
- American Regent, Inc.1 product
- Navinta LLC1 product
- Zydus Pharmaceuticals USA Inc.1 product
- ProPharma Distribution1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Preferred Pharmaceuticals Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (21)
- ANDA086242Heritage · October 23, 1978
- ANDA088467Pliva · May 1, 1984
- ANDA088468Pliva · May 1, 1984
- ANDA089097Pliva · December 18, 1985
- ANDA089098Pliva · December 18, 1985
- ANDA040136Am Regent · June 30, 1997
- ANDA040388Fresenius Kabi USA · March 13, 2001
- ANDA040901Hetero Labs Ltd III · September 12, 2008
- ANDA090255Invagen Pharms · December 15, 2008
- ANDA040730Rising · April 21, 2009
- ANDA040858Heritage Pharms Inc · February 26, 2010
- ANDA200737Alkem Labs Ltd · December 7, 2012
- ANDA202938Navinta LLC · March 28, 2013
- ANDA200770Strides Pharma · May 3, 2013
- ANDA203845Cadila Pharms Ltd · September 18, 2014
- ANDA205236Sciegen Pharms · May 26, 2017
- ANDA213667Hikma · December 18, 2020
- ANDA215147Eugia Pharma · February 13, 2023
- ANDA211010Macleods Pharms · August 21, 2024
- ANDA217501Kindos · June 2, 2025
- ANDA219797Baxter Hlthcare Corp · July 17, 2025
Shortage status
Current shortage · updated August 27, 2026 · first posted April 7, 2020
| Product | Furosemide, Injection, 10 mg/mL, 2 mL (NDC 71288-205-03) |
|---|---|
| Availability | Available |
| Company | Meitheal Pharmaceuticals, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 8, 2017 · Class II · Terminated · D-0668-2017
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-S — Mckesson Medical Surgical
-
July 28, 2015 · Class III · Terminated · D-1327-2015
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Z — Fresenius Kabi USA, LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Hydralazine Hydrochloride, Remedyrepack Inc., effective September 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →