Hydralazine Hydrochloride 50 mg Tablet, Film Coated, 120-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Arteriolar Vasodilator class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Hydralazine is used to treat high blood pressure. Hydralazine is in a class of medications called vasodilators. It works by relaxing the blood vessels so that blood can flow more easily through the body. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressur...
Read the full MedlinePlus article ↗- 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. K...
- What exactly is hydralazine supposed to do for me?
- 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 star...
- How do I take my hydralazine tablets — do they need to be taken with food?
Patient education
Supplement & herbal interactions
Hydralazine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.045 | $5.34 / 120 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.0607 | $7.28 / 120 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydralazine Hydrochloride 50 mg 00904-7449-61 | Major | 100 tablets | $0.045 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 23155-0003-01 | Heritage | 100 tablets | $0.045 | — | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 23155-0834-01 | Heritage | 100 tablets | $0.045 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 31722-0521-01 | Camber | 100 tablets | $0.045 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 50111-0328-01 | Teva | 100 tablets | $0.045 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 50228-0184-01 | ScieGen | 100 tablets | $0.045 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 51079-0076-20 | Mylan | 100 tablets | $0.045 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 60687-0833-01 | American | 100 tablets | $0.045 | AA | Availability likely | — |
| Hydralazine Hydrochloride 50 mgthis 62135-0581-12 | Chartwell | 120 tablets | $0.045 | — | Availability likely | — |
| HydrALAZINE Hydrochloride 50 mg 64380-0735-06 | Strides | 100 tablets | $0.045 | — | Availability likely | — |
| HydrALAZINE Hydrochloride 50 mg 76282-0311-01 | Exelan | 100 tablets | $0.045 | — | Availability likely | — |
| Hydralazine Hydrochloride 50 mg 33342-0376-11 | Macleods | 100 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 43063-0392-90 | PD-Rx | 90 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 48433-0048-20 | Safecor | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 50090-0139-00 | A-S | 100 tablets | — | AA | Discontinued | — |
| Hydralazine Hydrochloride 50 mg 50090-6608-00 | A-S | 90 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 50090-6684-00 | A-S | 90 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 50090-7210-01 | A-S | 60 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 50090-7212-00 | A-S | 90 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 51655-0916-26 | Northwind | 90 tablets | — | — | Discontinued | — |
| Hydralazine Hydrochloride 50 mg 55154-0187-00 | Cardinal | 10 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 55154-2140-00 | Cardinal | 10 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 55154-5085-00 | Cardinal | 10 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 63629-5246-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 63629-8497-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 67046-1517-03 | Coupler | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 67877-0291-01 | Ascend | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 68071-1940-03 | NuCare | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 68462-0343-01 | Glenmark | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 70518-4007-00 | REMEDYREPACK | 30 tablets | — | AA | FDA listed | — |
| HydrALAZINE Hydrochloride 50 mg 71205-0072-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 71209-0017-05 | Cadila | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 71335-9756-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 71610-0562-60 | Aphena | 90 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 72162-1537-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 72241-0005-05 | Modavar | 100 tablets | — | AA | FDA listed | — |
| Hydralazine 50 mg 75834-0127-00 | Nivagen | 1000 tablets | — | AA | Discontinued | — |
| Hydralazine Hydrochloride 50 mg 77771-0184-01 | Radha | 100 tablets | — | AA | FDA listed | — |
| HydrALAZINE Hydrochloride 50 mg 67046-2080-03 | Coupler | 30 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 50 mg 55154-0287-00 | Cardinal | 10 tablets | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62135-0581-12 You're viewing this | 120 TABLET, FILM COATED in 1 BOTTLE (62135-581-12) | 2023-05-09 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.
⏱️ Dosage and Administration ▾
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. In a few resistant patients, up to 300 mg of hydrALAZINE daily may be required for a significant antihypertensive effect.
In such cases, a lower dosage of hydrALAZINE 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.
⛔ Contraindications ▾
CONTRAINDICATIONS Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.
⚠️ Warnings ▾
WARNINGS In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug.Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary.
(See PRECAUTIONS, Laboratory Tests .)
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reactions with hydrALAZINE are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency.
Common : Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. Less Frequent : Digestive: constipation, paralytic ileus. Cardiovascular: hypotension, paradoxical pressor response, edema.
Respiratory : dyspnea. Neurologic: peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. Genitourinary: difficulty in urination.
Hematologic: blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. Hypersensitive Reactions: rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. Other: nasal congestion, flushing, lacrimation, conjunctivitis.
🆘 Overdosage ▾
OVERDOSAGE Acute Toxicity: No deaths due to acute poisoning have been reported. Highest known dose survived: adults, 10 g orally. Oral LD 50 in rats: 173 and 187 mg/kg.
Signs and Symptoms: Signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing. Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock. Treatment: There is no specific antidote.
The gastric contents should be evacuated, taking adequate precautions against aspiration and for protection of the airway. An activated charcoal slurry may be instilled if conditions permit. These manipulations may have to be omitted or carried out after cardiovascular status has been stabilized, since they might precipitate cardiac arrhythmias or increase the depth of shock.
Support of the cardiovascular system is of primary importance. Shock should be treated with plasma expanders. If possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia.
Tachycardia responds to beta blockers. Digitalization may be necessary, and renal function should be monitored and supported as required. No experience has been reported with extracorporeal or peritoneal dialysis.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Although the precise mechanism of action of hydrALAZINE is not fully understood, the major effects are on the cardiovascular system. HydrALAZINE apparently lowers blood pressure by exerting a peripheral vasodilating effect through a direct relaxation of vascular smooth muscle. HydrALAZINE, by altering cellular calcium metabolism, interferes with the calcium movements within the vascular smooth muscle that are responsible for initiating or maintaining the contractile state.
The peripheral vasodilating effect of hydrALAZINE results in decreased arterial blood pressure (diastolic more than systolic); decreased peripheral vascular resistance; and an increased heart rate, stroke volume, and cardiac output. The preferential dilatation of arterioles, as compared to veins, minimizes postural hypotension and promotes the increase in cardiac output. HydrALAZINE usually increases renin activity in plasma, presumably as a result of increased secretion of renin by the renal juxtaglomerular cells in response to reflex sympathetic discharge.
This increase in renin activity leads to the production of angiotensin II, which then causes stimulation of aldosterone and consequent sodium reabsorption. HydrALAZINE also maintains or increases renal and cerebral blood flow. HydrALAZINE is rapidly absorbed after oral administration, and peak plasma levels are reached at 1 to 2 hours.
Plasma levels of apparent hydrALAZINE decline with a half-life of 3 to 7 hours. Binding to human plasma protein is 87%. Plasma levels of hydrALAZINE vary widely among individuals.
HydrALAZINE is subject to polymorphic acetylation; slow acetylators generally have higher plasma levels of hydrALAZINE and require lower doses to maintain control of blood pressure. HydrALAZINE undergoes extensive hepatic metabolism; it is excreted mainly in the form of metabolites in the urine.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP 10 mg - round, convex, pink film-coated tablet engraved with HP above 1 on one side and plain on the other side. Bottle of 120 tablets, NDC 62135-579-12 25 mg - round, convex, pink film-coated tablet engraved with HP above 2 on one side and plain on the other side. Bottle of 120 tablets, NDC 62135-580-12 50 mg - round, convex, pink film-coated tablet engraved with HP above 3 on one side and plain on the other side.
Bottle of 120 tablets, NDC 62135-581-12 100 mg - round, convex, pink film-coated tablet engraved with HP above 4 on one side and plain on the other side. Bottle of 120 tablets, NDC 62135-582-12 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Chartwell RX, LLC.
Congers, NY 10920 Revised : 04/2023 L71441
📋 Description ▾
DESCRIPTION HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether.
It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.
HYDRALAZINE HYDROCHLORIDE