HYDRALAZINE HYDROCHLORIDE 20 mg/mL Injection, 1 mL
🆔 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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0.65 mg / 1 mL
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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103.6 mg / 1 mL
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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0.35 mg / 1 mL
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydralazine Hydrochloride 20 mg/mL 00404-9787-01 | Henry | 1 vial | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 00517-0901-25 | American | 25 vials | — | AP | FDA listed | — |
| HydrALAZINE hydrochloride 20 mg/mL 00641-6231-25 | Hikma | 25 vials | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 43066-0041-25 | Baxter | 25 vials | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 51662-1376-01 | HF | 1 ml | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mLthis 51662-1388-01 | HF | 1 ml | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 51662-1648-03 | HF | 25 pouches | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 55150-0400-25 | Eugia | 25 vials | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 55154-9554-05 | Cardinal | 5 vials | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 55154-9587-05 | Cardinal | 5 vials | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 63323-0614-55 | Fresenius | 25 vials | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 68475-0514-02 | Navinta | 25 vials | — | AP | FDA listed | — |
| hydrALAZINE Hydrochloride 20 mg/mL 70518-3659-01 | REMEDYREPACK | 25 vials | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 70710-1988-07 | Zydus | 25 vials | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 71288-0205-02 | Meitheal | 25 vials | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 71872-7145-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 71872-7268-01 | Medical | 1 vial | — | AP | FDA listed | — |
| HydrALAZINE hydrochloride 20 mg/mL 71872-7274-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 71872-7339-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Hydralazine Hydrochloride 20 mg/mL 72572-0265-25 | Civica, | 25 vials | — | AP | FDA listed | — |
| hydrALAZINE Hydrochloride 20 mg/mL 84549-0614-55 | ProPharma | 1 ml | — | AP | 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
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51662-1388-01 You're viewing this | 1 mL in 1 VIAL, SINGLE-DOSE (51662-1388-1) | 2019-10-07 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
Indications & Usage Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
⏱️ Dosage and Administration ▾
Dosage & 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 ▾
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 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. Adverse Reactions
🆘 Overdosage ▾
Overdosage 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.
Overdosage
🧬 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. The average maximal decrease in blood pressure usually occurs 10 to 80 minutes after administration of hydralazine hydrochloride injection.
No other pharmacokinetic data on hydralazine hydrochloride injection are available.
📦 How Supplied / Storage and Handling ▾
How Supplied HYDRALAZINE HYDROCHLORIDE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1388-1 HYDRALAZINE HYDROCHLORIDE INJECTION, USP 20mg/mL 1mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Hydralazine Hydrochloride Injection USP, 20 mg/mL Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Akorn Manufactured by: Akorn, Inc.
Lake Forest, IL 60045 HY00N Rev. 06/16 How Supplied
📋 Description ▾
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 colorless solution. Each mL contains: Active: Hydralazine Hydrochloride USP, 20 mg Preservatives: Methylparaben NF, 0.65 mg; Propylparaben NF, 0.35 mg 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 C8H8N4•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 275°C, with decomposition, and has a molecular weight of 196.64.
Structure