Hydralazine Hydrochloride 10 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
Where does this data come from?
🩺 Clinical
- 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.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
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 | $0.027 | $2.71 / 100 tablet |
| Medicaid paysCMS SDUD · 12 mo | $0.7379 | $73.79 / 100 tablet |
| Medicare drug plans payPart D · Q2 2026 | $0.0607 | $6.07 / 100 tablet |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydralazine Hydrochloride 10 mg 00904-7447-61 | Major | 100 tablets | $0.027 | AA | Availability likely | — |
| Hydralazine Hydrochloride 10 mg 23155-0001-01 | Heritage | 100 tablets | $0.027 | — | Discontinued | — |
| Hydralazine Hydrochloride 10 mg 23155-0832-01 | Heritage | 100 tablets | $0.027 | AA | Availability likely | — |
| Hydralazine Hydrochloride 10 mg 31722-0519-01 | Camber | 100 tablets | $0.027 | AA | Availability likely | — |
| Hydralazine Hydrochloride 10 mg 50111-0398-01 | Teva | 100 tablets | $0.027 | AA | Availability likely | — |
| Hydralazine Hydrochloride 10 mg 50228-0182-01 | ScieGen | 100 tablets | $0.027 | AA | Availability likely | — |
| Hydralazine Hydrochloride 10 mgthis 51079-0074-20 | Mylan | 100 tablets | $0.027 | AA | Availability likely | — |
| Hydralazine Hydrochloride 10 mg 60687-0811-01 | American | 100 tablets | $0.027 | AA | Availability likely | — |
| Hydralazine Hydrochloride 10 mg 62135-0579-12 | Chartwell | 120 tablets | $0.027 | — | Availability likely | — |
| HydrALAZINE Hydrochloride 10 mg 76282-0309-01 | Exelan | 100 tablets | $0.027 | — | Availability likely | — |
| Hydralazine Hydrochloride 10 mg 33342-0374-11 | Macleods | 100 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 48433-0046-20 | Safecor | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 63629-8493-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 63629-8494-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| HydrALAZINE Hydrochloride 10 mg 64380-0733-06 | Strides | 100 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 67046-1520-03 | Coupler | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 67046-1609-03 | Coupler | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 67877-0293-01 | Ascend | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 68071-2055-03 | NuCare | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 68462-0341-01 | Glenmark | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 70518-4022-00 | REMEDYREPACK | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 71205-0091-30 | Proficient | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 71335-1685-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 71335-2307-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 72162-1535-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 10 mg 77771-0182-01 | Radha | 100 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
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51079-0074-20 You're viewing this | 100 BLISTER PACK in 1 CARTON (51079-074-20) / 1 TABLET in 1 BLISTER PACK (51079-074-01) | 2007-12-26 | 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.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category C Animal studies indicate that hydralazine is teratogenic in mice at 20 to 30 times the maximum daily human dose of 200 to 300 mg and possibly in rabbits at 10 to 15 times the maximum daily human dose, but that it is nonteratogenic in rats. Teratogenic effects observed were cleft palate and malformations of facial and cranial bones. There are no adequate and well-controlled studies in pregnant women.
Although clinical experience does not include any positive evidence of adverse effects on the human fetus, hydralazine should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established in controlled clinical trials, although there is experience with the use of hydralazine in pediatric patients. The usual recommended oral starting dosage is 0.75 mg/kg of body weight daily in four divided doses. Dosage may be increased gradually over the next 3 to 4 weeks to a maximum of 7.5 mg/kg or 200 mg daily.
🆘 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 Orange, round, convex, unscored tablets, debossed with “PLIVA 398” on one side and plain on the other side. They are available as follows: NDC 51079-074-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 25 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 327” on one side and plain on the other side.
They are available as follows: NDC 51079-075-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 50 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 328” on one side and plain on the other side. They are available as follows: NDC 51079-076-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured in Czech Republic by: TEVA CZECH INDUSTRIES s.r.o.
Opava-Komarov, Czech Republic Manufactured for: TEVA PHARMACEUTICALS USA, Inc. North Wales, PA 19454 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A.
S-11344 R3 4/20
📋 Description ▾
DESCRIPTION Hydralazine Hydrochloride Tablets USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: C 8 H 8 N 4 ·HCl M.W. 196.64 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 anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Chem structure
💬 Information for Patients ▾
Information for Patients Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.