Hydralazine Hydrochloride 100 mg Tablet, 100-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 used to treat high blood pressure (hypertension). The tablet form is taken at home on a daily schedule, while the injectable form is reserved for hospital use when b...
- It works by relaxing the walls of your arteries, which allows them to widen. When arteries are wider, blood flows through them more easily and your blood pressure drops. It's not a...
- How does hydralazine lower my blood pressure?
- Common side effects include headache, nausea, a fast heartbeat, flushing, and dizziness — these often settle as your body adjusts or if your dose is tweaked. You should call your d...
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.
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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 H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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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 PNR0YF693Y
A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
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UNII KO5GYV0DCB
Microcrystalline cellulose is a purified plant fiber used as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and improves how the medicine breaks apart in your body.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
6 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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💲 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 | $0.075 | $7.46 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.1472 | $14.72 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.0607 | $6.07 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydralazine Hydrochloride 100 mg 00904-7450-61 | Major | 100 tablets | $0.075 | AA | Availability likely | — |
| Hydralazine Hydrochloride 100 mgthis 23155-0835-01 | Heritage | 100 tablets | $0.075 | AA | Availability likely | — |
| Hydralazine Hydrochloride 100 mg 31722-0522-01 | Camber | 100 tablets | $0.075 | AA | Availability likely | — |
| Hydralazine Hydrochloride 100 mg 50111-0397-01 | Teva | 100 tablets | $0.075 | AA | Availability likely | — |
| Hydralazine Hydrochloride 100 mg 50228-0185-01 | ScieGen | 100 tablets | $0.075 | AA | Availability likely | — |
| Hydralazine Hydrochloride 100 mg 62135-0582-12 | Chartwell | 120 tablets | $0.075 | — | Availability likely | — |
| HydrALAZINE Hydrochloride 100 mg 64380-0736-06 | Strides | 100 tablets | $0.075 | — | Availability likely | — |
| Hydralazine Hydrochloride 100 mg 72241-0006-05 | Modavar | 100 tablets | $0.075 | AA | Availability likely | — |
| HydrALAZINE Hydrochloride 100 mg 76282-0312-01 | Exelan | 100 tablets | $0.075 | — | Availability likely | — |
| Hydralazine Hydrochloride 100 mg 00615-7973-05 | NCS | 15 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 33342-0377-11 | Macleods | 100 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 43353-0124-05 | Aphena | 4200 tablets | — | AA | FDA listed | — |
| HydrALAZINE Hydrochloride 100 mg 43353-0205-05 | Aphena | 4200 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 63629-8495-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 67877-0290-01 | Ascend | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 68071-5285-01 | NuCare | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 68462-0344-01 | Glenmark | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 68788-8087-01 | Preferred | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 70518-4352-00 | REMEDYREPACK | 90 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 71209-0018-05 | Cadila | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 71335-1589-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 71335-9722-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 71610-0549-05 | Aphena | 4200 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 72162-1538-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydralazine 100 mg 75834-0128-00 | Nivagen | 1000 tablets | — | AA | Discontinued | — |
| Hydralazine Hydrochloride 100 mg 77771-0185-01 | Radha | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 100 mg 82804-0197-30 | Proficient | 30 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?
🗺️ Medicaid utilization & spend
🔬 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 |
|---|---|---|---|
| 23155-0835-01 You're viewing this | 100 TABLET in 1 BOTTLE (23155-835-01) | 2023-08-02 | 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 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.
⛔ 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 are available as: 10 mg – Round, peach core tablet, debossed EP on one side and 101 on the reverse side. NDC 23155-832-01 Bottles of 100 NDC 23155-832-10 Bottles of 1000 25 mg – Round, peach, core tablet, debossed EP over 102 on one side and plain on the reverse side. NDC 23155-833-01 Bottles of 100 NDC 23155-833-10 Bottles of 1000 50 mg – Round, peach, core tablet, debossed EP over 103 on one side and plain on the reverse side.
NDC 23155-834-01 Bottles of 100 NDC 23155-834-10 Bottles of 1000 100 mg – Round, Peach, core tablet, debossed EP over 104 on one side and plain on the reverse side. NDC 23155-835-01 Bottles of 100 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].
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Stallion Laboratories Private Limited Gallops Industrial Park-II, Ahmedabad-382110, Gujarat, India Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1-866-901-DRUG (3784) Revised: 06/2025 logo
📋 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. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain magnesium stearate, microcrystalline cellulose, orange lake blend, silicon dioxide, and sodium starch glycolate.
The orange lake blend consists of FD&C yellow #6. structure-image