NDC 67877-290-05 (67877-0290-05) — Hydralazine Hydrochloride 100 mg

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67877-290-05

Product NDC 67877-290

11-digit billing NDC 67877029005

RxCUI 905199, 905222, 905225, 905395

UNII FD171B778Y

UPC 0367877293011

Application # ANDA200737

SPL Set ID e7bfec3d-5222-4a26-8f99-6c2a28e14aa6

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 2010-05-24

Route ORAL

Dosage form TABLET

Substance HYDRALAZINE HYDROCHLORIDE

TE code (Orange Book) AA · RLD · RS

Quick answers

RxCUI (RxNorm): 905199

Why two NDCs? The FDA registers this code as 67877-290-05 — 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 → 67877-0290-05. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 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.

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.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

VITAMIN B6 Moderate Depletion COENZYME Q10 Insufficient Evidence

🧪 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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026

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 · Q2 2026	$0.0607	$30.35 / 500 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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 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	Marketing start	Marketing end	Status
67877-0290-01 67877-290-01 Main listing	100 TABLET in 1 BOTTLE	2010-05-24	—	Active
67877-0290-05 You're viewing this	500 TABLET in 1 BOTTLE	2010-05-24	—	Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?

This is a 500-count package — 500 tablet in 1 bottle.

How does this package differ from NDC 67877-0290-01?

Both are Hydralazine Hydrochloride 100 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 67877-0290-01 is the 100 tablets package.

What NDC number is used to bill for this package of Hydralazine Hydrochloride 100 mg Tablet?

Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Hydralazine Hydrochloride 100 mg 00904-7450-61	Major	100 tablets	$0.072	AA	Availability likely	—
Hydralazine Hydrochloride 100 mg 23155-0835-01	Heritage	100 tablets	$0.072	AA	Availability likely	—
Hydralazine Hydrochloride 100 mg 31722-0522-01	Camber	100 tablets	$0.072	AA	Availability likely	—
Hydralazine Hydrochloride 100 mg 50111-0397-01	Teva	100 tablets	$0.072	AA	Availability likely	—
Hydralazine Hydrochloride 100 mg 50228-0185-01	ScieGen	100 tablets	$0.072	AA	Availability likely	—
Hydralazine Hydrochloride 100 mg 62135-0582-12	Chartwell	120 tablets	$0.072	—	Availability likely	—
HydrALAZINE Hydrochloride 100 mg 64380-0736-06	Strides	100 tablets	$0.072	AA	Availability likely	—
Hydralazine Hydrochloride 100 mg 72241-0006-05	Modavar	100 tablets	$0.072	AA	Availability likely	—
HydrALAZINE Hydrochloride 100 mg 76282-0312-01	Exelan	100 tablets	$0.072	—	Availability likely	—
Hydralazine Hydrochloride 100 mg 00615-7973-05	NCS	15 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mg 33342-0377-11	Macleods	100 tablets	—	—	FDA listed	—
Hydralazine Hydrochloride 100 mg 43353-0124-05	Aphena	4200 tablets	—	AA	FDA listed	—
HydrALAZINE Hydrochloride 100 mg 43353-0205-05	Aphena	4200 tablets	—	—	FDA listed	—
Hydralazine Hydrochloride 100 mg 63629-8495-01	Bryant	100 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mgthis 67877-0290-05	Ascend	500 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mg 68071-5285-01	NuCare	100 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mg 68462-0344-01	Glenmark	100 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mg 68788-8087-01	Preferred	100 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mg 70518-4352-00	REMEDYREPACK	90 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mg 71209-0018-05	Cadila	100 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mg 71335-1589-01	Bryant	30 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mg 71335-9722-01	Bryant	30 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mg 71610-0549-05	Aphena	4200 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mg 72162-1538-01	Bryant	100 tablets	—	AA	FDA listed	—
Hydralazine 100 mg 75834-0128-00	Nivagen	1000 tablets	—	AA	Discontinued	—
Hydralazine Hydrochloride 100 mg 77771-0185-01	Radha	100 tablets	—	AA	FDA listed	—
Hydralazine Hydrochloride 100 mg 82804-0197-30	Proficient	30 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Sep 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2010

On the market since

May 2010

📍

2026

Currently FDA-listed

16 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.

FDA Orange Book · refreshed Sep 3, 2026

What it looks like

Color Orange

ShapeRound

Imprint290

Size12 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

FDA label on DailyMed · label index refreshed Oct 1, 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

FDA label on DailyMed · label index refreshed Oct 1, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

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

LabelerAscend Laboratories, LLC

Application holderALKEM LABORATORIES LTD

FDA applicationANDA200737 (ANDA)

Labeler code67877

First marketedMay 2010

Product typeHuman Prescription Drug

Portfolio349 products on file

🔎 All NDCs from Ascend Laboratories, LLC

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

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 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel

🎯 Indications and Usage 10 words ▾

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

⏱️ Dosage and Administration 147 words ▾

DOSAGE & 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 . In a few resistant patients, up to 300 mg of HydrALAZINE daily may be required for a significant antihypertensive effect.

In such cases, a lower dosage of HydrALAZINE 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 13 words ▾

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

⚠️ Warnings 67 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 132 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.

🆘 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 215 words ▾

HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP: 10 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘293’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-293-01 Bottles of 500 Tablets NDC 67877-293-05 Bottles of 1000 Tablets NDC 67877-293-10 25 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘292’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-292-01 Bottles of 500 Tablets NDC 67877-292-05 Bottles of 1000 Tablets NDC 67877-292-10 50 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘291’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-291-01 Bottles of 500 Tablets NDC 67877-291-05 Bottles of 1000 Tablets NDC 67877-291-10 100 mg Orange colored, slightly mosaic, circular, biconvex uncoated tablets debossed with ‘290’ on one side and plain on other side Bottles of 100 Tablets NDC 67877-290-01 Bottles of 500 Tablets NDC 67877-290-05 Dispense in a tight, light-resistant container.

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: ALKEM LABORATORIES LIMITED H.O.: ALKEM HOUSE, Senapati Bapat Marg, Lower Parel, Mumbai - 400 013, INDIA Distributed by: Ascend Laboratories Parsippany, NJ 07054 Revised: December,2017 PT 1368-02

📋 Description 109 words ▾

DESCRIPTION HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: 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 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg HydrALAZINE hydrochloride, USP. Tablets also contain microcrystalline cellulose, sodium starch glycolate, stearic acid, povidone K-30, colloidal silicon dioxide, mannitol and FD&C Yellow No 6. structure

⚠️ 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 he… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 92 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL HydrALAZINE Hydrochloride Tablets, USP 10 mg - Container Label NDC 67877-293-01 HydrALAZINE Hydrochloride Tablets, USP 10 mg Rx Only 100 Tablets HydrALAZINE Hydrochloride Tablets, USP 25 mg - Container Label NDC 67877-292-05 HydrALAZINE Hydrochloride Tablets, USP 25 mg Rx Only 500 Tablets HydrALAZINE Hydrochloride Tablets, USP 50 mg - Container Label NDC 67877-291-10 HydrALAZINE Hydrochloride Tablets, USP 50 mg Rx Only 1000 Tablets HydrALAZINE Hydrochloride Tablets, USP 100 mg - Container Label NDC 67877-290-01 HydrALAZINE Hydrochloride Tablets, USP 100 mg Rx Only 100 Tablets 100s-10mg 500s-25mg 1000s-50mg 100s-100mg

Glossary — plain-language definitions of medical terms used in this label:

systemic lupus erythematosus: A long-term autoimmune disease in which the immune system attacks the body's own tissues, affecting joints, skin, kidneys, and other organs.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

angina pectoris: Chest pain or a squeezing feeling that happens when the heart muscle does not get enough blood and oxygen.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

arthralgia: Joint pain.

Carcinogenesis, Mutagenesis, Impairment of Fertility: A label section reporting whether lab or animal studies found effects on cancer risk, genes, or the ability to have children.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

conjunctivitis: Redness and irritation of the thin lining over the white of the eye, often called pink eye.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

fertility: The natural ability to become pregnant or to father a child.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hepatic metabolism: The breakdown of a medicine by the liver into other substances the body can use or remove.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

ileus: A slowdown or stop in the normal movement of the intestines, so food and waste do not pass through.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

ischemia: Reduced blood flow to a part of the body, so that area does not get enough oxygen.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

lymphadenopathy: Swollen or enlarged lymph nodes, often felt as lumps in the neck, armpits, or groin.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

pruritus: Itching of the skin.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

urticaria: Raised, itchy welts on the skin, commonly called hives.

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	✓ Available
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.

“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 Ascend Laboratories, LLC. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (67877-0290-01). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Ascend Laboratories, LLC 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.

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