Hydralazine Hydrochloride 25 mg Tablet, 1,000-count — NDC 23155-833-10 (Billing 23155-0833-10)
This is a package of 1,000 tablets of Hydralazine Hydrochloride 25 mg Tablet from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., marketed since Aug 2023 and currently FDA-listed; retail pharmacies pay about $0.0357 per tablet (NADAC).
NDC database record
One package, one record: these facts belong to NDC 23155-833-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 23155 labeler · 833 product · 10 package
- Package marketed since
- Aug 2, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 1,000 EA per package
- Barcode (UPC)
- 0323155834017, 0323155835014, 0323155833010, 0323155832013
- Medicaid fills, this package
- 32,891 prescriptions in the last four reported quarters
- FDA record last changed
- Sep 17, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 000286
- GCN: 01243
- GPI-14 (Medi-Span): 36400010100310
- HICL (First Databank): 000089
- AHFS class code: 24:08.16.00
- RxCUI (RxNorm): 905199
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Arteriolar Vasodilator class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $35.70 / 1000 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.1215 | $121.50 / 1000 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.0607 | $60.70 / 1000 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 23155-0833-01 23155-833-01 Main listing | 100 TABLET in 1 BOTTLE | $0.0357 / ea | $3.57 | 2023-08-02 | — | Active |
| 23155-0833-10 You're viewing this | 1000 TABLET in 1 BOTTLE | $0.0357 / ea | $35.72 | 2023-08-02 | — | 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 ($0.0357 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 53% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 23155-0833-01?
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.
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 mgthis 23155-0833-10 | Heritage | 1000 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 | AA | Availability likely | — |
| HydrALAZINE Hydrochloride 25 mg 76282-0310-01 | Exelan | 100 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?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac... labeler code 23155
- Perphenazine 16 mg Tablet NDC 23155-802-01
- Oxybutynin Chloride 5 mg Tablet NDC 23155-810-01
- Cabergoline .5 mg Tablet NDC 23155-823-73
- Mycophenolate mofetil 250 mg Capsule NDC 23155-830-01
- Acetazolamide 500 mg/5mL Injection, Powder, Lyophilized, For Solution NDC 23155-831-31
- Hydralazine Hydrochloride 10 mg Tablet NDC 23155-832-01
- Hydralazine Hydrochloride 50 mg Tablet NDC 23155-834-01
- Hydralazine Hydrochloride 100 mg Tablet NDC 23155-835-01
- Mycophenolate mofetil 500 mg Tablet, Film Coated NDC 23155-836-01
- Cyclosporine 25 mg Capsule, Liquid Filled NDC 23155-837-30
- Cyclosporine 50 mg Capsule, Liquid Filled NDC 23155-838-30
- Cyclosporine 100 mg Capsule, Liquid Filled NDC 23155-839-30
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
⚠️ Precautions ▾
PRECAUTIONS General Myocardial stimulation produced by hydrALAZINE can cause anginal attacks and ECG changes of myocardial ischemia. The drug has been implicated in the production of myocardial infarction. It must, therefore, be used with caution in patients with suspected coronary artery disease.
The “hyperdynamic” circulation caused by hydrALAZINE may accentuate specific cardiovascular inadequacies. For example, hydrALAZINE may increase pulmonary artery pressure in patients with mitral valvular disease. The drug may reduce the pressor responses to epinephrine.
Postural hypotension may result from hydrALAZINE but is less common than with ganglionic blocking agents. It should be used with caution in patients with cerebral vascular accidents. In hypertensive patients with normal kidneys who are treated with hydrALAZINE, there is evidence of increased renal blood flow and a maintenance of glomerular filtration rate.
In some instances where control values were below normal, improved renal function has been noted after administration of hydrALAZINE. However, as with any antihypertensive agent, hydrALAZINE should be used with caution in patients with advanced renal damage. Peripheral neuritis, evidenced by paresthesia, numbness, and tingling, has been observed.
Published evidence suggests an antipyridoxine effect, and that pyridoxine should be added to the regimen if symptoms develop. Information for Patients Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed. Laboratory Tests Complete blood counts and antinuclear antibody titer determinations are indicated before and periodically during prolonged therapy with hydrALAZINE even though the patient is asymptomatic.
These studies are also indicated if the patient develops arthralgia, fever, chest pain, continued malaise, or other unexplained signs or symptoms. A positive antinuclear antibody titer requires that the physician carefully weigh the implications of the test results against the benefits to be derived from antihypertensive therapy with hydrALAZINE. Blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, and purpura, have been reported.
If such abnormalities develop, therapy should be discontinued. 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 are used concomitantly. Drug/Food Interactions Administration of hydrALAZINE with food results in higher plasma levels. Carcinogenesis, Mutagenesis, Impairment of Fertility In a lifetime study in Swiss albino mice, there was a statistically significant increase in the incidence of lung tumors (adenomas and adenocarcinomas) of both male and female mice given hydrALAZINE continuously in their drinking water at a dosage of about 250 mg/kg per day (about 80 times the maximum recommended human dose).
In a 2-year carcinogenicity study of rats given hydrALAZINE by gavage at dose levels of 15, 30, and 60 mg/kg/day (approximately 5 to 20 times the recommended human daily dosage), microscopic examination of the liver revealed a small, but statistically significant, increase in benign neoplastic nodules in male and female rats from the high-dose group and in female rats from the intermediate-dose group. Benign interstitial cell tumors of the testes were also significantly increased in male rats from the high-dose group.
The tumors observed are common in aged rats and a significantly increased incidence was not observed until 18 months of treatment. HydrALAZINE was shown to be mutagenic in bacterial systems (Gene Mutation and DNA Repair) and in one of two rats and one rabbit hepatoc… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 10 mg NDC 23155- 832 -01 HydrALAZINE Hydrochloride Tablets, USP 10 mg 100 Tablets Rx only 10 mg-100s-count 10mg-100s-avet
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 25 mg NDC 23155- 833 -01 HydrALAZINE Hydrochloride Tablets, USP 25 mg 100 Tablets Rx only 25 mg-100s-count 25mg-100s-avet
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 50 mg NDC 23155- 834 -01 HydrALAZINE Hydrochloride Tablets, USP 50 mg 100 Tablets Rx only 50 mg-100s-count 50mg-100s-avet
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 100 mg NDC 23155- 835 -01 HydrALAZINE Hydrochloride Tablets, USP 100 mg 100 Tablets Rx only 100 mg-100s-count 100mg-100s-avet