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Hydralazine Hydrochloride 50 mg Tablet, Film Coated, 90-count — NDC 43063-392-90 (Billing 43063-0392-90)

by PD-Rx Pharmaceuticals, Inc. · 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 90 tablets of Hydralazine Hydrochloride 50 mg Tablet, Film Coated from PD-Rx Pharmaceuticals, Inc., marketed since Apr 2007 and currently FDA-listed. It is this product's only package size.

NDC 43063-0392-90
🏷️ FDA NDC (as labeled) 43063-392-90 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43063-392-90
Product NDC 43063-392
11-digit billing NDC 43063039290
RxCUI 905395
UNII FD171B778Y
Application # ANDA086242
SPL Set ID e9450e82-329f-4fd8-a0b3-3e8e22715965
Established class (EPC) Arteriolar Vasodilator
Physiologic effect Arteriolar Vasodilation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-04-06
Route ORAL
Dosage form TABLET, FILM COATED
Substance HYDRALAZINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 905395
Why two NDCs? The FDA registers this code as 43063-392-90 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43063-0392-90. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Arteriolar Vasodilator class.

Pharmacologic class Arteriolar Vasodilator
Drug family (ATC) Hydrazinophthalazine derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Hydralazine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
2
Nutrient depletion considerations

Hydralazine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Hydralazine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer 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 · Q2 2026 $0.0607 $5.46 / 90 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43063-0392-90 You're viewing this Main listing 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2011-03-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydralazine Hydrochloride 50 mg 00904-7449-61 Major 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 23155-0003-01 Heritage 100 tablets $0.045 — Discontinued —
Hydralazine Hydrochloride 50 mg 23155-0834-01 Heritage 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 31722-0521-01 Camber 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 50111-0328-01 Teva 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 50228-0184-01 ScieGen 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 51079-0076-20 Mylan 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 60687-0833-01 American 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 62135-0581-12 Chartwell 120 tablets $0.045 — Availability likely —
HydrALAZINE Hydrochloride 50 mg 64380-0735-06 Strides 100 tablets $0.045 AA Availability likely —
HydrALAZINE Hydrochloride 50 mg 76282-0311-01 Exelan 100 tablets $0.045 — Availability likely —
Hydralazine Hydrochloride 50 mg 33342-0376-11 Macleods 100 tablets — — FDA listed —
Hydralazine Hydrochloride 50 mgthis 43063-0392-90 PD-Rx 90 tablets — — FDA listed —
Hydralazine Hydrochloride 50 mg 48433-0048-20 Safecor 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 50090-0139-00 A-S 100 tablets — AA Discontinued —
Hydralazine Hydrochloride 50 mg 50090-6608-00 A-S 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 50090-6684-00 A-S 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 50090-7210-01 A-S 60 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 50090-7212-00 A-S 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 51655-0916-26 Northwind 90 tablets — — Discontinued —
Hydralazine Hydrochloride 50 mg 55154-0187-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 55154-2140-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 55154-5085-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 63629-5246-01 Bryant 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 63629-8497-01 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 67046-1517-03 Coupler 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 67877-0291-01 Ascend 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 68071-1940-03 NuCare 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 68462-0343-01 Glenmark 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 70518-4007-00 REMEDYREPACK 30 tablets — AA FDA listed —
HydrALAZINE Hydrochloride 50 mg 71205-0072-30 Proficient 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 71209-0017-05 Cadila 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 71335-9756-01 Bryant 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 71610-0562-60 Aphena 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 72162-1537-00 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 72241-0005-05 Modavar 100 tablets — AA FDA listed —
Hydralazine 50 mg 75834-0127-00 Nivagen 1000 tablets — AA Discontinued —
Hydralazine Hydrochloride 50 mg 77771-0184-01 Radha 100 tablets — AA FDA listed —
HydrALAZINE Hydrochloride 50 mg 67046-2080-03 Coupler 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 55154-0287-00 Cardinal 10 tablets — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2007
On the market since
Apr 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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 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.
  • 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.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPD-Rx Pharmaceuticals, Inc.
Application holderHERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC
FDA applicationANDA086242 (ANDA)
Labeler code43063
First marketedApr 2007
Product typeHuman Prescription Drug
Portfolio834 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 10 words ▾

INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.

⏱️ Dosage and Administration 152 words ▾

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 12 words ▾

CONTRAINDICATIONS Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.

⚠️ Warnings 65 words ▾

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 152 words ▾

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.

To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 189 words ▾

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 ~1 min read ▾

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 33 words ▾

HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP 50 mg - round, convex, pink film-coated tablet engraved with HP above 3 on one side and plain on the other side NDC 43063-392-90 Bottles of 90

📦 Storage and Handling 53 words ▾

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. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

📋 Description 101 words ▾

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 FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.

Image

⚠️ Precautions ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 14 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Hydralazine Hydrochloride Tablets, USP, 50 mg Rx Only 43063392 Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by PD-Rx Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PD-Rx Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 43063-0383-06 · PD-Rx 43063-0395-14 · PD-Rx →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.