Hydralazine Hydrochloride
Tablet · Oral, Intramuscular, Intravenous
Current shortage
Furosemide, Injection, 10 mg/mL, 2 mL (NDC 71288-205-03) – Available (Meitheal Pharmaceuticals, Inc., updated Aug 27, 2026)
Check wholesalers for inventory
Uses
Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
Dosage and administration
When there is urgent need, therapy in the hospitalized patient may be initiated intramuscularly or as a rapid intravenous bolus injection directly into the vein. Hydralazine hydrochloride injection should be used only when the drug cannot be given orally. The usual dose is 20 to 40 mg, repeated as necessary. Certain patients (especially those with marked renal damage) may require a lower dose. Blood pressure should be checked frequently. It may begin to fall within a few minutes after injection, with the average maximal decrease occurring in 10 to 80 minutes. In cases where there has been increased intracranial pressure, lowering the blood pressure may increase cerebral ischemia. Most patients can be transferred to oral hydralazine hydrochloride within 24 to 48 hours. The product should be used immediately after the vial is opened. It should not be added to infusion solutions. Hydralazine hydrochloride injection may discolor upon contact with metal; discolored solutions should be discarded. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications
Hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.
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 ).
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. 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 hydrochloride. 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 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 injection are used concomitantly. 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 hepatocyte in vitro DNA repair studies. Additional in vivo and in vitro studies using lymphoma cells, germinal cells, and fibroblasts from mice, bone marrow cells from chinese hamsters and fibroblasts from human cell lines did not demonstrate any mutagenic potential for hydralazine. The extent to which these findings indicate a risk to man is uncertain. While long-term clinical observation has not suggested that human cancer is associated with hydralazine use, epidemiologic studies have so far been insufficient to arrive at any conclusions. Pregnancy: Teratogenic effects. 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. Nursing Mothers: Hydralazine has been shown to be excreted in breast milk. 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 hydrochloride in children. The usual recommended parenteral dosage, administered intramuscularly or intravenously, is 1.7 to 3.5 mg/kg of body weight daily, divided into four to six doses.
Side effects
Adverse reactions with hydralazine hydrochloride 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
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. 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.
Description
Hydralazine hydrochloride injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Hydralazine hydrochloride injection, USP is a sterile, nonpyrogenic clear, colorless solution. Each mL contains: Active: Hydralazine hydrochloride USP, 20 mg Preservative Free Formulation Inactives: Propylene glycol USP, 103.6 mg; sodium hydroxide and/or hydrochloric acid USP to adjust pH (3.4 to 4.4) and water for injection. Hydralazine hydrochloride USP is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: Molecular Formula C 8 H 8 N 4
• HCl 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 288.90°C, with decomposition, and has a molecular weight of 196.64. Image
How supplied
Hydralazine hydrochloride injection USP, 20 mg/mL is supplied as follows: NDC 70710-1988-1 1 mL Single-dose Vial NDC 70710-1988-7 1 mL Single-dose Vial Packaged in boxes of 25 Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Made in India 30590224R1 June 2024
Label text from the FDA structured product label by Zydus Pharmaceuticals USA Inc. (revised May 6, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Hydralazine Hydrochloride in 146 products
Hydralazine Hydrochloride NDC products (146)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7212 | Hydralazine Hydrochloride 50 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7210 | Hydralazine Hydrochloride 50 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6684 | Hydralazine Hydrochloride 50 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6608 | Hydralazine Hydrochloride 50 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-0139 | Hydralazine Hydrochloride 50 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-0137 | Hydralazine Hydrochloride 25 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 60687-811 | Hydralazine Hydrochloride 10 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-822 | Hydralazine Hydrochloride 25 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-833 | Hydralazine Hydrochloride 50 mg/1 Tablet | American Health Packaging | ANDA |
| 0517-0901 | Hydralazine Hydrochloride 20 mg/mL Injection, Solution | American Regent, Inc. | ANDA |
| 71610-562 | Hydralazine Hydrochloride 50 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-561 | Hydralazine Hydrochloride 25 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-549 | Hydralazine Hydrochloride 100 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-205 | Hydralazine Hydrochloride 100 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-124 | Hydralazine Hydrochloride 100 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 67544-657 | Hydralazine Hydrochloride 25 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 67877-290 | Hydralazine Hydrochloride 100 mg/1 Tablet | Ascend Laboratories, LLC | ANDA |
| 67877-291 | Hydralazine Hydrochloride 50 mg/1 Tablet | Ascend Laboratories, LLC | ANDA |
| 67877-292 | Hydralazine Hydrochloride 25 mg/1 Tablet | Ascend Laboratories, LLC | ANDA |
| 67877-293 | Hydralazine Hydrochloride 10 mg/1 Tablet | Ascend Laboratories, LLC | ANDA |
| 43066-041 | Hydralazine Hydrochloride 20 mg/mL Injection | Baxter Healthcare Corporation | ANDA |
| 63629-8497 | Hydralazine Hydrochloride 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-8494 | Hydralazine Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-8493 | Hydralazine Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-5246 | Hydralazine Hydrochloride 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1536 | Hydralazine Hydrochloride 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1535 | Hydralazine Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1521 | Hydralazine Hydrochloride 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1537 | Hydralazine Hydrochloride 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1538 | Hydralazine Hydrochloride 100 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-8757 | Hydralazine Hydrochloride 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-8495 | Hydralazine Hydrochloride 100 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-8496 | Hydralazine Hydrochloride 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-9756 | Hydralazine Hydrochloride 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0202 | Hydralazine Hydrochloride 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1589 | Hydralazine Hydrochloride 100 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1685 | Hydralazine Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2307 | Hydralazine Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2352 | Hydralazine Hydrochloride 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-9722 | Hydralazine Hydrochloride 100 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71209-016 | Hydralazine Hydrochloride 25 mg/1 Tablet | Cadila Pharmaceuticals Limited | ANDA |
| 71209-017 | Hydralazine Hydrochloride 50 mg/1 Tablet | Cadila Pharmaceuticals Limited | ANDA |
| 71209-018 | Hydralazine Hydrochloride 100 mg/1 Tablet | Cadila Pharmaceuticals Limited | ANDA |
| 31722-519 | Hydralazine Hydrochloride 10 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-520 | Hydralazine Hydrochloride 25 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-521 | Hydralazine Hydrochloride 50 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-522 | Hydralazine Hydrochloride 100 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA |
| 55154-2141 | Hydralazine Hydrochloride 25 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-9587 | Hydralazine Hydrochloride 20 mg/mL Injection | Cardinal Health 107, LLC | ANDA |
| 55154-9554 | Hydralazine Hydrochloride 20 mg/mL Injection | Cardinal Health 107, LLC | ANDA |
| 55154-5689 | Hydralazine Hydrochloride 25 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-5085 | Hydralazine Hydrochloride 50 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-2140 | Hydralazine Hydrochloride 50 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-0287 | Hydralazine Hydrochloride 50 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-0187 | Hydralazine Hydrochloride 50 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-0186 | Hydralazine Hydrochloride 25 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 62135-579 | Hydralazine Hydrochloride 10 mg/1 Tablet, Film Coated | Chartwell RX, LLC | ANDA |
| 62135-580 | Hydralazine Hydrochloride 25 mg/1 Tablet, Film Coated | Chartwell RX, LLC | ANDA |
| 62135-581 | Hydralazine Hydrochloride 50 mg/1 Tablet, Film Coated | Chartwell RX, LLC | ANDA |
| 62135-582 | Hydralazine Hydrochloride 100 mg/1 Tablet, Film Coated | Chartwell RX, LLC | ANDA |
| 72572-265 | Hydralazine Hydrochloride 20 mg/mL Injection, Solution | Civica, Inc. | ANDA |
| 67046-1660 | Hydralazine Hydrochloride 25 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-2080 | Hydralazine Hydrochloride 50 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1517 | Hydralazine Hydrochloride 50 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1520 | Hydralazine Hydrochloride 10 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1609 | Hydralazine Hydrochloride 10 mg/1 Tablet | Coupler LLC | ANDA |
| 55150-400 | Hydralazine Hydrochloride 20 mg/mL Injection | Eugia US LLC | ANDA |
| 76282-311 | Hydralazine Hydrochloride 50 mg/1 Tablet | Exelan Pharmaceuticals Inc. | ANDA |
| 76282-310 | Hydralazine Hydrochloride 25 mg/1 Tablet | Exelan Pharmaceuticals Inc. | ANDA |
| 76282-309 | Hydralazine Hydrochloride 10 mg/1 Tablet | Exelan Pharmaceuticals Inc. | ANDA |
| 76282-312 | Hydralazine Hydrochloride 100 mg/1 Tablet | Exelan Pharmaceuticals Inc. | ANDA |
| 63323-614 | Hydralazine Hydrochloride 20 mg/mL Injection | Fresenius Kabi USA, LLC | ANDA |
| 68462-344 | Hydralazine Hydrochloride 100 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-343 | Hydralazine Hydrochloride 50 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-342 | Hydralazine Hydrochloride 25 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-341 | Hydralazine Hydrochloride 10 mg/1 Tablet | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 0404-9787 | Hydralazine Hydrochloride 20 mg/mL Injection | Henry Schein, Inc. | ANDA |
| 23155-003 | Hydralazine Hydrochloride 50 mg/1 Tablet, Film Coated | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-835 | Hydralazine Hydrochloride 100 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-834 | Hydralazine Hydrochloride 50 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-833 | Hydralazine Hydrochloride 25 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-832 | Hydralazine Hydrochloride 10 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 51662-1648 | Hydralazine Hydrochloride 20 mg/mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1388 | Hydralazine Hydrochloride 20 mg/mL Injection | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1376 | Hydralazine Hydrochloride 20 mg/mL Injection | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 0641-6231 | Hydralazine Hydrochloride 20 mg/mL Injection, Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 33342-377 | Hydralazine Hydrochloride 100 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-376 | Hydralazine Hydrochloride 50 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-375 | Hydralazine Hydrochloride 25 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 33342-374 | Hydralazine Hydrochloride 10 mg/1 Tablet | Macleods Pharmaceuticals Limited | ANDA |
| 0904-7448 | Hydralazine Hydrochloride 25 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-7450 | Hydralazine Hydrochloride 100 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-7449 | Hydralazine Hydrochloride 50 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-7447 | Hydralazine Hydrochloride 10 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 71872-7145 | Hydralazine Hydrochloride 20 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7268 | Hydralazine Hydrochloride 20 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7274 | Hydralazine Hydrochloride 20 mg/mL Injection, Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7339 | Hydralazine Hydrochloride 20 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71288-205 | Hydralazine Hydrochloride 20 mg/mL Injection | Meitheal Pharmaceuticals Inc. | ANDA |
| 72241-004 | Hydralazine Hydrochloride 25 mg/1 Tablet | Modavar Pharmaceuticals LLC | ANDA |
| 72241-006 | Hydralazine Hydrochloride 100 mg/1 Tablet | Modavar Pharmaceuticals LLC | ANDA |
| 72241-005 | Hydralazine Hydrochloride 50 mg/1 Tablet | Modavar Pharmaceuticals LLC | ANDA |
| 51079-074 | Hydralazine Hydrochloride 10 mg/1 Tablet | Mylan Institutional Inc. | ANDA |
| 51079-075 | Hydralazine Hydrochloride 25 mg/1 Tablet | Mylan Institutional Inc. | ANDA |
| 51079-076 | Hydralazine Hydrochloride 50 mg/1 Tablet | Mylan Institutional Inc. | ANDA |
| 68475-514 | Hydralazine Hydrochloride 20 mg/mL Injection | Navinta LLC | ANDA |
| 0615-7973 | Hydralazine Hydrochloride 100 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 82868-045 | Hydralazine Hydrochloride 25 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 68071-2055 | Hydralazine Hydrochloride 10 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-1940 | Hydralazine Hydrochloride 50 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-5285 | Hydralazine Hydrochloride 100 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 43063-392 | Hydralazine Hydrochloride 50 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-8087 | Hydralazine Hydrochloride 100 mg/1 Tablet | Preferred Pharmaceuticals, Inc. | ANDA |
| 82804-197 | Hydralazine Hydrochloride 100 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-081 | Hydralazine Hydrochloride 25 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-901 | Hydralazine Hydrochloride 25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-091 | Hydralazine Hydrochloride 10 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-072 | Hydralazine Hydrochloride 50 mg/1 Tablet | Proficient Rx LP | ANDA |
| 84549-614 | Hydralazine Hydrochloride 20 mg/mL Injection | ProPharma Distribution | ANDA |
| 77771-185 | Hydralazine Hydrochloride 100 mg/1 Tablet | Radha Pharmaceuticals, Inc. | ANDA |
| 77771-184 | Hydralazine Hydrochloride 50 mg/1 Tablet | Radha Pharmaceuticals, Inc. | ANDA |
| 77771-183 | Hydralazine Hydrochloride 25 mg/1 Tablet | Radha Pharmaceuticals, Inc. | ANDA |
| 77771-182 | Hydralazine Hydrochloride 10 mg/1 Tablet | Radha Pharmaceuticals, Inc. | ANDA |
| 70518-4352 | Hydralazine Hydrochloride 100 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4064 | Hydralazine Hydrochloride 25 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4022 | Hydralazine Hydrochloride 10 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4007 | Hydralazine Hydrochloride 50 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-3852 | Hydralazine Hydrochloride 25 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-3659 | Hydralazine Hydrochloride 20 mg/mL Injection | REMEDYREPACK INC. | ANDA |
| 70518-2551 | Hydralazine Hydrochloride 25 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 48433-047 | Hydralazine Hydrochloride 25 mg/1 Tablet | Safecor Health, LLC | ANDA |
| 48433-048 | Hydralazine Hydrochloride 50 mg/1 Tablet | Safecor Health, LLC | ANDA |
| 48433-046 | Hydralazine Hydrochloride 10 mg/1 Tablet | Safecor Health, LLC | ANDA |
| 50228-182 | Hydralazine Hydrochloride 10 mg/1 Tablet | ScieGen Pharmaceuticals, Inc. | ANDA |
| 50228-183 | Hydralazine Hydrochloride 25 mg/1 Tablet | ScieGen Pharmaceuticals, Inc. | ANDA |
| 50228-185 | Hydralazine Hydrochloride 100 mg/1 Tablet | ScieGen Pharmaceuticals, Inc. | ANDA |
| 50228-184 | Hydralazine Hydrochloride 50 mg/1 Tablet | ScieGen Pharmaceuticals, Inc. | ANDA |
| 64380-733 | Hydralazine Hydrochloride 10 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-734 | Hydralazine Hydrochloride 25 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-735 | Hydralazine Hydrochloride 50 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-736 | Hydralazine Hydrochloride 100 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 50111-327 | Hydralazine Hydrochloride 25 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 50111-328 | Hydralazine Hydrochloride 50 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 50111-397 | Hydralazine Hydrochloride 100 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 50111-398 | Hydralazine Hydrochloride 10 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 70710-1988 | Hydralazine Hydrochloride 20 mg/mL Injection | Zydus Pharmaceuticals USA Inc. | ANDA |
Hydralazine Hydrochloride recalls
- D-0184-2024 Jan 3, 2024 · Class II · Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - D-0668-2017 Apr 19, 2017 · Class II · Terminated
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation. - D-1327-2015 Aug 19, 2015 · Class III · Terminated
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Frequently asked questions
What is Hydralazine Hydrochloride used for?
Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
What are the side effects of Hydralazine Hydrochloride?
Adverse reactions with hydralazine hydrochloride 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,… See the full label for the complete list.
Who makes Hydralazine Hydrochloride?
Hydralazine Hydrochloride is listed by 43 labelers in the FDA NDC directory, including A-S Medication Solutions, American Health Packaging, American Regent, Inc., Aphena Pharma Solutions - Tennessee, LLC.
Has Hydralazine Hydrochloride been recalled?
The FDA enforcement database lists 3 recalls for Hydralazine Hydrochloride, most recently D-0184-2024 (class ii): CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.