HydrALAZINE Hydrochloride 25 mg Tablet, 1,000-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.
💊 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 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 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.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
5 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?
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 | $0.036 | $35.60 / 1000 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 | $60.70 / 1000 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydralazine Hydrochloride 25 mg 00904-7448-61 | Major | 100 tablets | $0.036 | AA | Availability likely | — |
| Hydralazine Hydrochloride 25 mg 23155-0002-01 | Heritage | 100 tablets | $0.036 | — | Discontinued | — |
| Hydralazine Hydrochloride 25 mg 23155-0833-01 | Heritage | 100 tablets | $0.036 | AA | Availability likely | — |
| Hydralazine Hydrochloride 25 mg 31722-0520-01 | Camber | 100 tablets | $0.036 | AA | Availability likely | — |
| Hydralazine Hydrochloride 25 mg 50111-0327-01 | Teva | 100 tablets | $0.036 | AA | Availability likely | — |
| Hydralazine Hydrochloride 25 mg 50228-0183-01 | ScieGen | 100 tablets | $0.036 | AA | Availability likely | — |
| Hydralazine Hydrochloride 25 mg 51079-0075-20 | Mylan | 100 tablets | $0.036 | AA | Availability likely | — |
| Hydralazine Hydrochloride 25 mg 60687-0822-01 | American | 100 tablets | $0.036 | AA | Availability likely | — |
| Hydralazine Hydrochloride 25 mg 62135-0580-12 | Chartwell | 120 tablets | $0.036 | — | Availability likely | — |
| HydrALAZINE Hydrochloride 25 mg 64380-0734-06 | Strides | 100 tablets | $0.036 | — | Availability likely | — |
| HydrALAZINE Hydrochloride 25 mgthis 76282-0310-10 | Exelan | 1000 tablets | $0.036 | — | Availability likely | — |
| Hydralazine Hydrochloride 25 mg 33342-0375-11 | Macleods | 100 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 48433-0047-20 | Safecor | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 50090-0137-00 | A-S | 100 tablets | — | AA | Discontinued | — |
| Hydralazine Hydrochloride 25 mg 51655-0305-26 | Northwind | 90 tablets | — | — | Discontinued | — |
| Hydralazine Hydrochloride 25 mg 55154-0186-00 | Cardinal | 10 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 55154-2141-00 | Cardinal | 10 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 55154-5689-00 | Cardinal | 10 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 55289-0133-60 | PD-Rx | 60 tablets | — | — | Discontinued | — |
| Hydralazine Hydrochloride 25 mg 63187-0901-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 63629-5696-01 | Bryant | 30 tablets | — | — | Discontinued | — |
| Hydralazine Hydrochloride 25 mg 63629-8496-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 63629-8757-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 67046-1660-03 | Coupler | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 67544-0657-60 | Aphena | 90 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 67877-0292-01 | Ascend | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 68462-0342-01 | Glenmark | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 70518-2551-00 | REMEDYREPACK | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 70518-3852-00 | REMEDYREPACK | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 70518-4064-02 | REMEDYREPACK | 180 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 71209-0016-05 | Cadila | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 71335-0202-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 71335-2352-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 71610-0561-60 | Aphena | 90 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 72162-1521-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 72162-1536-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 72241-0004-05 | Modavar | 100 tablets | — | AA | FDA listed | — |
| Hydralazine 25 mg 75834-0126-00 | Nivagen | 1000 tablets | — | AA | Discontinued | — |
| Hydralazine Hydrochloride 25 mg 77771-0183-01 | Radha | 100 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 82804-0081-30 | Proficient | 30 tablets | — | AA | FDA listed | — |
| Hydralazine Hydrochloride 25 mg 82868-0045-30 | Northwind | 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?
🔬 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 | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 76282-0310-01 | 100 TABLET in 1 BOTTLE (76282-310-01) | $0.0356 / ea | $3.56 | 2016-05-20 | Active |
| 76282-0310-10 You're viewing this | 1000 TABLET in 1 BOTTLE (76282-310-10) | $0.0356 / ea | $35.59 | 2016-05-20 | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0356 NADAC).
Pack size FAQ
What quantity is in NDC 76282-0310-10?
What is the difference between NDC 76282-0310-10 and NDC 76282-0310-01?
What NDC number is used to bill for this package of HydrALAZINE Hydrochloride 25 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.
⏱️ Dosage and Administration ▾
2 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 - Orange, round, biconvex tablets debossed with 'IG' on one side and "309" on the other, supplied in bottles of 100 (NDC 76282-309-01) and 1000 (NDC 76282-309-10). 25 mg - Orange, round, biconvex tablets debossed with 'IG' on one side and "310" on the other, supplied in bottles of 100 (NDC 76282-310-01) and 1000 (NDC 76282-310-10). 50 mg - Orange, round, biconvex tablets debossed with 'IG' on one side and "311" on the other, supplied in bottles of 100 (NDC 76282-311-01) and 1000 (NDC 76282-311-10).
100 mg -Orange, round, biconvex tablets debossed with 'IG' on one side and "312" on the other, supplied in bottles of 100 (NDC 76282-312-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. 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. Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432 Rev: 06/20 Barcode: 312-06-2020 Rx only
📋 Description ▾
DESCRIPTION HydrALAZINE Hydrochloride Tablets 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 microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, FD&C Yellow #6 and stearic acid.