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Hydralazine

Hydralazine is a blood vessel–relaxing medication used to treat high blood pressure (hypertension), available in oral tablets for ongoing treatment and as an injection for urgent blood pressure control.

Brand names ApresolineDralzine
Drug class Arteriolar Vasodilator
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 80 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Hydralazine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Hydralazine is an older blood pressure medicine, around since the 1950s and available as a generic, that relaxes artery walls so the vessels widen. The tablets are usually an add-on when first-choice medicines fall short, and the injection is a hospital option for urgent control. Many people tolerate it well once the dose settles, though headache, flushing, a fast or pounding heartbeat and a stuffy nose are common early on. The thing to watch for is a lupus-like reaction, where the immune system turns on the joints, skin or kidneys, so report joint pain, fever or a rash promptly.

Clinical pearls

  • The lupus-like risk climbs with dose, so prescribers keep the dose as low as works and add other medicines instead.
  • Report new chest pain right away; prescribers often add a beta-blocker to calm the fast heartbeat that can strain the heart.
  • Mention numbness or tingling in your hands or feet; it is a known nerve effect, sometimes treated with vitamin B6.
  • If you take an MAO inhibitor antidepressant, make sure every prescriber knows, since the combination can unsettle blood pressure.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet, Injection
Earliest FDA record1953
Companies listing it with the FDA42
FDA label last updatedAug 31, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Hydralazine, written from its FDA label.

What Hydralazine is used for

▾

Hydralazine is used to treat high blood pressure across several products and forms.

  • Tablets (Hydralazine, Hydralazine Hcl, HydrALAZINE Hydrochloride): treat essential hypertension — high blood pressure without a single identifiable cause — either on their own or combined with other blood pressure medications.
  • Injection (hydrALAZINE Hydrochloride): used in a hospital setting for severe high blood pressure when oral medication cannot be taken, or when there is an urgent need to lower blood pressure quickly.

How Hydralazine works

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Hydralazine lowers blood pressure by directly relaxing the smooth muscle in the walls of your arteries. It does this by interfering with calcium movement inside those muscle cells — calcium is what tells muscle to contract and stay tight. When the muscle relaxes, arteries widen, blood flows more easily, and pressure drops. It mainly widens arteries rather than veins, which helps keep blood pressure stable when you stand up and supports heart output.

Because it preferentially acts on arterioles (the smallest arteries), it also helps maintain good blood flow to the kidneys and brain. People break down hydralazine at different speeds depending on their genetics (a process called acetylation), so some individuals need lower doses than others to get the same effect.

Hydralazine dosage

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For tablets, therapy is started at a low dose taken several times a day, then gradually increased over the first couple of weeks until blood pressure is well controlled. Your doctor will find the lowest effective dose for you. If higher doses are needed but cause side effects, your doctor may add other blood pressure medications rather than continuing to raise the hydralazine dose.

The injection is administered by a healthcare professional in a hospital — either into a vein or a muscle — and is used only when oral tablets aren't an option. Most patients switch to oral tablets within 24 to 48 hours. Always follow your prescriber's instructions; do not adjust your dose on your own.

Dosing details from the FDA-approved label

From the Hydralazine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Injection (intramuscular or rapid intravenous bolus) for hospitalized patients with urgent need, when the drug cannot be given orally
    • The usual dose is 20 mg to 40 mg, repeated as necessary
    • Certain patients (especially those with marked renal damage) may require a lower dose
  • Oral tablets, initiation and titration
    • Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week
    • For the second and subsequent weeks, increase dosage to 50 mg four times daily
    • For maintenance, adjust dosage to the lowest effective levels
  • Oral tablets, resistant patients
    • In a few resistant patients, up to 300 mg daily may be required for a significant antihypertensive effect
    • A lower dosage combined with a thiazide and/or reserpine or a beta blocker may be considered
    • Maximum: up to 300 mg daily
    • When combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels. The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydralazine hydrochloride tablets. In a few resistant patients, up to 300 mg of hydralazine hydrochloride tablets daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydralazine hydrochloride tablets combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.

Read the full Dosage and Administration section on DailyMed →

Hydralazine side effects

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Like most blood pressure medicines, hydralazine can cause some side effects, especially when the dose is higher. Common ones include:

Common side effects

  • Headache
  • Nausea, vomiting, or loss of appetite
  • Diarrhea
  • Rapid heartbeat (tachycardia)
  • Heart palpitations
  • Flushing or nasal congestion
  • Dizziness

When to get medical help

  • Call your doctor if you develop joint pain, fever, rash, or symptoms that feel like lupus — hydralazine can trigger a lupus-like syndrome in some people
  • Seek help right away for chest pain (angina) or signs of a heart attack
  • Tell your doctor about numbness, tingling, or weakness in your hands or feet (nerve-related side effects)
  • Contact your doctor if you notice unusual bruising, persistent fever, or signs of a blood problem (such as unusual tiredness or infections)
  • Get medical help for signs of a serious allergic reaction: rash, hives, fever, chills, or jaundice (yellowing of skin or eyes, which may indicate liver involvement)

Hydralazine warnings and precautions

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  • Lupus-like syndrome: Hydralazine can cause a condition that mimics systemic lupus erythematosus, including kidney inflammation. This is more likely with higher doses. Symptoms (joint pain, fever, rash) usually improve after stopping the drug, but effects can persist for years in some people. Long-term steroid treatment may be needed.
  • Higher doses, higher risk: The risk of serious reactions rises with larger doses. Your doctor will always aim for the lowest dose that works.
  • Increased intracranial pressure: In patients with raised pressure in the skull, rapidly lowering blood pressure with the injection can reduce blood flow to the brain — medical staff monitor for this in hospital settings.
  • Blood and nerve effects: Hydralazine can rarely affect blood cell counts or cause nerve-related symptoms like numbness and tingling. Tell your doctor if you notice these.

Hydralazine interactions

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Hydralazine can interact with certain other medications, which may cause blood pressure to drop too much or cause other problems.

  • MAO inhibitors (a class of antidepressants, e.g., phenelzine, tranylcypromine): use together with caution — can affect blood pressure unpredictably.
  • Diazoxide injection: Combining with hydralazine can cause a severe, dangerous drop in blood pressure. Patients must be closely monitored for several hours.
  • Other potent injectable blood pressure medications: Using alongside hydralazine increases the risk of an excessive blood pressure fall; continuous monitoring is required.

Interactions listed in the FDA-approved label

From the Hydralazine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • MAO inhibitors: The label says MAO inhibitors should be used with caution in patients receiving hydralazine. Use with caution
  • Diazoxide and other potent parenteral antihypertensive drugs: Profound hypotensive episodes may occur when diazoxide injection and hydralazine hydrochloride tablets are used concomitantly. When used in combination with hydralazine, patients should be continuously observed for several hours for any excessive fall in blood pressure
Read the label’s full interactions text

Drug/Drug Interactions MAO inhibitors should be used with caution in patients receiving hydralazine. When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydralazine, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydralazine hydrochloride tablets are used concomitantly.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿136 supplements and herbs with documented Hydralazine interactions, ranked by severity Check Hydralazine against a supplement or herb →

Before taking Hydralazine

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  • Do not take hydralazine if you are allergic to it.
  • Do not take if you have coronary artery disease (narrowed or blocked arteries that supply the heart).
  • Do not take if you have mitral valve rheumatic heart disease (damage to the mitral heart valve caused by rheumatic fever).
  • Tell your doctor if you have kidney disease — especially significant kidney damage — as you may need a lower dose.
  • Tell your doctor about all medications you take, especially MAO inhibitors or other blood pressure drugs given by injection.
  • Tell your doctor if you have any personal or family history of lupus or autoimmune conditions.

Hydralazine overdose

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Taking too much hydralazine can cause a severe drop in blood pressure, rapid heartbeat, headache, and flushing of the skin. In serious cases, it can lead to reduced blood flow to the heart, irregular heart rhythms, or shock. There is no specific antidote — treatment focuses on supporting blood pressure and heart function, and you should seek emergency medical help immediately.

What Hydralazine does in the body

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Hydralazine primarily lowers blood pressure by widening arteries (arterioles), reducing the resistance your heart pumps against. It tends to lower the bottom (diastolic) blood pressure number more than the top (systolic) number. By preferentially dilating arteries rather than veins, it minimizes dizziness when standing and actually increases heart rate, stroke volume (amount of blood pumped per beat), and overall heart output. It also helps maintain blood flow to the kidneys and brain.

How your body processes Hydralazine

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After taking a tablet, hydralazine is absorbed quickly, with peak levels in the blood reached within 1 to 2 hours. It is heavily bound to proteins in the blood (about 87%) and is broken down extensively by the liver, with most of it leaving the body through the urine as metabolites. The time it takes for blood levels to drop by half (half-life) is roughly 3 to 7 hours, though this varies widely between people. Genetic differences in how fast people process (acetylate) the drug mean some individuals — called slow acetylators — build up higher levels and may need lower doses.

How to store Hydralazine

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Store at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required) KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

136

Supplements & herbs that interact with Hydralazine

136 supplements and herbal products have documented interactions with Hydralazine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 4
  • Moderate · 111
  • Minor · 21
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major AMERICAN MISTLETOE Major TYRAMINE Major ADRAFINIL Moderate AGMATINE Moderate ALGAL OIL Moderate ANDROGRAPHIS Moderate +128 more
Every supplement checked against Hydralazine — ranked by severity The full interaction hub: 4 major · 111 moderate · 21 minor · every one linked to its full report. Check Hydralazine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

2

Nutrient depletion considerations

Hydralazine has been associated with lower levels of 2 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Moderate · 1
  • Unrated · 1
VITAMIN B6 Moderate Depletion COENZYME Q10 Insufficient Evidence
See the full Hydralazine nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Hydralazine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Hydralazine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is hydralazine supposed to do for me?

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Hydralazine is a blood pressure–lowering medication. It works by relaxing the walls of your arteries so blood can flow through more easily, which brings your blood pressure down. Keeping blood pressure under control helps protect your heart, kidneys, and brain from long-term damage. Depending on what your doctor prescribed, you might take it as a daily tablet or, if you're in the hospital with a blood pressure emergency, receive it as an injection.

How do I take my hydralazine tablets — do they need to be taken with food?

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Your prescription label and your doctor's instructions are the best guide for your specific regimen. Tablets are generally taken several times a day, and your doctor will have started you at a lower dose and gradually increased it. The label doesn't specify taking it with or without food, so follow whatever your pharmacist or prescriber told you. The most important thing is to take it consistently — don't skip doses or stop on your own, even if you feel fine.

What side effects should I expect, and which ones mean I should call my doctor?

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Common side effects include headache, nausea, flushing, a faster-than-usual heartbeat, and dizziness — many of these settle down as your body adjusts or your dose is fine-tuned. The side effects worth calling your doctor about right away are joint pain, fever, or a rash (especially together), which can be signs of a lupus-like reaction that hydralazine can rarely cause. Also call if you notice numbness or tingling in your hands or feet, chest pain, unusual bruising, or yellowing of your skin or eyes.

I heard hydralazine can cause something like lupus — should I be worried?

▾
It's a real risk, but it's more likely at higher doses, and your doctor will aim to keep your dose as low as possible to control your blood pressure. The lupus-like syndrome can cause joint pain, fever, and rash. If it does happen and you stop the medication, symptoms usually improve — though your doctor will monitor you. Just be aware of those symptoms and report them early so your doctor can act quickly.

Are there any medications I should avoid while taking hydralazine?

▾
Yes — a few combinations need extra care. MAO inhibitors, which are sometimes used for depression, should be used very cautiously alongside hydralazine. If you ever need a strong injectable blood pressure medication like diazoxide in a hospital setting, your blood pressure will need to be watched closely because combining them can cause it to drop dangerously low. Always make sure every doctor and pharmacist you see knows you're taking hydralazine.

What happens if I miss a dose?

▾
Follow the guidance on your prescription label or ask your pharmacist — general missed-dose advice can vary depending on your specific regimen. As a rule, if it's close to the time of your next dose, skip the missed one and carry on as normal. Don't double up to make up for a missed dose. Consistent daily use is important for keeping your blood pressure stable, so try to take it at the same times each day.

Is Hydralazine available over the counter?

▾
No. Hydralazine is a prescription medicine: every Hydralazine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Hydralazine first available?

▾
The earliest FDA record we hold for Hydralazine is from 1953: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Hydralazine was first used.

Who makes Hydralazine?

▾
42 companies currently list Hydralazine products in the FDA's NDC Directory, including Bryant Ranch Prepack, Cardinal Health 107, LLC, Remedyrepack Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Hydralazine on HelloPharmacist

📊Hydralazine supplement interactions136 checked — ranked by severity 🌿Drug & Supplement CheckerHydralazine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Hydralazine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Hydralazine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Hydralazine forms and strengths (how it comes)

Hydralazine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Hydralazine, Hydralazine Hcl, and HydrALAZINE Hydrochloride tablets are used to treat essential hypertension (high blood pressure), either alone or combined with other blood pressure medications
Important instructions
  • Tablets are taken by mouth multiple times daily; your prescriber will start low and gradually increase your dose based on your response
  • Your doctor will adjust your dose to the lowest amount that controls your blood pressure
  • If a higher dose is needed but causes side effects, your doctor may combine a lower tablet dose with other blood pressure medications rather than continuing to increase the dose
  • Follow your prescriber's instructions and prescription label exactly — do not change your dose without guidance
Available strengths 4 strengths
10 mg 25 mg 50 mg 100 mg
204 FDA-listed product records ⓘ

Injection

Into a muscle · Into a vein
How this form is used
What it may be used for
  • hydrALAZINE Hydrochloride injection is used in hospitalized patients for severe high blood pressure when oral medication cannot be taken or when blood pressure must be lowered urgently
Important instructions
  • hydrALAZINE Hydrochloride injection is given by a healthcare professional directly into a vein (IV) or into a muscle (IM) in a hospital setting only
  • Blood pressure is checked frequently after injection, as it may begin to fall within minutes
  • hydrALAZINE Hydrochloride injection should not be added to IV infusion bags — it is given as a direct injection only, and the vial must be used immediately after opening
  • Most patients are switched to oral hydralazine tablets within 24 to 48 hours once their condition is stable
Available strengths 1 strength
20 mg/mL
37 FDA-listed product records ⓘ

Hydralazine on the U.S. market: products, makers and brands

How Hydralazine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

42 companies list 146 Hydralazine product records with the FDA, mostly as tablet, injection; the earliest marketing or approval year on record is 1953. Brand names on the directory include Apresoline, Dralzine; the rest are generics.

2
Dose forms ⓘ
42
Labelers (makers, repackagers, distributors)
1
Brand names
146
FDA-listed product records ⓘ
1953
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack13%
Cardinal Health 107, LLC6%
Remedyrepack Inc.5%
A-S Medication Solutions4%
Aphena Pharma Solutions - Tennessee, LLC4%
Coupler LLC3%
Other makers64%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Hydralazine is used (Medicaid data)

A general measure of how commonly Hydralazine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Hydralazine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

805,117
Medicaid prescriptions filled (Q1–Q4 2025)
$10.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Hydralazine prescribed? Of the 1,601 medications we measure, Hydralazine ranks #199 by Medicaid prescriptions — more than 88% of them.

Where Hydralazine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #199 of 1,601
#194 Meclizine 846,276 Rx #195 Erythromycin Ophthalmi... 841,932 Rx #196 Lactulose 835,520 Rx #197 Haloperidol 821,226 Rx #198 Calcium Chloride / Pot... 809,101 Rx #199 Hydralazine 805,117 Rx #200 Valsartan and Sacubitr... 792,623 Rx #201 Medroxyprogesterone In... 789,786 Rx #202 Bictegravir, Emtricita... 772,594 Rx #203 Desvenlafaxine 769,380 Rx #204 Fexofenadine 767,005 Rx

Utilization by Hydralazine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 25 mg oral tablet is the most-dispensed Hydralazine product — about 35% of these Medicaid prescriptions.

hydralazine hydrochloride 25 MG Oral Tablet Most dispensed

282,823 Medicaid prescriptions (Q1–Q4 2025) 35% of Hydralazine prescriptions shown $2.9M gross reimbursement (before rebates) ≈ $10 per prescription (gross)

Summed across the 16 of 112 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 905225

hydralazine hydrochloride 50 MG Oral Tablet

265,185 Medicaid prescriptions (Q1–Q4 2025) 33% of Hydralazine prescriptions shown $3M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 16 of 114 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 905395

hydralazine hydrochloride 100 MG Oral Tablet

165,062 Medicaid prescriptions (Q1–Q4 2025) 21% of Hydralazine prescriptions shown $2.6M gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 6 of 59 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 905222

hydralazine hydrochloride 10 MG Oral Tablet

67,268 Medicaid prescriptions (Q1–Q4 2025) 8% of Hydralazine prescriptions shown $650,632 gross reimbursement (before rebates) ≈ $9.67 per prescription (gross)

Summed across the 11 of 65 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 905199

1 ML hydralazine hydrochloride 20 MG/ML Injection

24,779 Medicaid prescriptions (Q1–Q4 2025) 3% of Hydralazine prescriptions shown $1.7M gross reimbursement (before rebates) ≈ $67 per prescription (gross)

Summed across the 9 of 43 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 966571

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Hydralazine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 58 of 393 listed Hydralazine NDCs with Medicaid activity.

Compare Hydralazine products

A representative set of FDA-listed product records for Hydralazine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 122 of 146 products — FDA National Drug Code Directory. See every product, package size and price: browse all 146 Hydralazine NDCs →

Hydralazine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Hydralazine recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Jan 26, 2022 · Terminated · CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
  • HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. NDC: 23155-002-01 Lots: Batch G210553, G210551 FDA record D-0184-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Hydralazine RxCUI 5470 2 dose forms · 5 strengths

Look up RxCUI 5470 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Hydralazine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 25 mg $0.036 per tablet NDC details & price history
Tablet · Oral 50 mg $0.045 per tablet NDC details & price history
Tablet · Oral 10 mg $0.027 per tablet NDC details & price history
Tablet, Film Coated · Oral 50 mg $0.045 per tablet NDC details & price history
Tablet, Film Coated · Oral 25 mg $0.036 per tablet NDC details & price history
Tablet, Film Coated · Oral 10 mg $0.027 per tablet NDC details & price history
Tablet, Film Coated · Oral 100 mg $0.072 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Hydralazine brand names

Hydralazine is sold under 2 brand names in the FDA directory — Apresoline, Dralzine. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Apresoline Dralzine

Who makes Hydralazine: manufacturers and labelers

42 companies list Hydralazine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Cardinal Health 107, LLC, Remedyrepack Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 19 Cardinal Health 107, LLC 9 Remedyrepack Inc. 7 A-S Medication Solutions 6 Aphena Pharma Solutions - Tennessee, LLC 6 Coupler LLC 5 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 5 Proficient Rx LP 5 Ascend Laboratories, LLC 4 Camber Pharmaceuticals, Inc. 4 Chartwell RX, LLC 4 Exelan Pharmaceuticals Inc. 4 Glenmark Pharmaceuticals Inc., USA 4 Macleods Pharmaceuticals Limited 4 Major Pharmaceuticals 4 Medical Purchasing Solutions, LLC 4 Radha Pharmaceuticals, Inc. 4 ScieGen Pharmaceuticals, Inc. 4 Strides Pharma Science Limited 4 Teva Pharmaceuticals USA, Inc. 4 American Health Packaging 3 Cadila Pharmaceuticals Limited 3 HF Acquisition Co LLC, DBA HealthFirst 3 Modavar Pharmaceuticals LLC 3

…and 18 more on the FDA NDC directory.

Hydralazine drug class (RxNorm)

Hydralazine belongs to the Arteriolar Vasodilator class.

Pharmacologic class Arteriolar Vasodilator
Drug family (ATC) Hydrazinophthalazine derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Hydralazine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 31, 2026
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Hydralazine.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Hydralazine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
80
Finished products in the current FDA directory
146
Companies listing them (makers, repackagers, distributors)
42
FDA labeler codes behind them ⓘ
48
Linked representative label ⓘ
Nivagen Pharmaceuticals, Inc.
Linked label effective
Aug 31, 2026
Composite sections available
16
Linked SPL Set ID
1fd8cf42-66ae-4af5-a5ae-7c9679a0e532
Linked SPL Document ID
544c9b57-32ea-4f48-a383-73e51da0d2f2
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Nivagen Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →