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Hydralazine Hydrochloride 10 mg Tablet, 1,000-count — NDC 50111-0398-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydralazine Hydrochloride 10 mg Tablet, 1,000-count — NDC 50111-398-03 (Billing 50111-0398-03)

by Teva Pharmaceuticals USA, Inc. · 1000 TABLET in 1 BOTTLE

This is a package of 1,000 tablets of Hydralazine Hydrochloride 10 mg Tablet from Teva Pharmaceuticals USA, Inc., marketed since Sep 1990 and currently FDA-listed; retail pharmacies pay about $0.0270 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 50111-0398-03
🏷️ FDA NDC (as labeled) 50111-398-03 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.0270 NADAC Per package$27.00 / 1000 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1085/unit · Part D plans $0.0607/unit — full pricing hub ↓
Main listing for product 50111-398 · Also comes in: 100 tablets 50111-398-01
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) 50111-398-03
Product NDC 50111-398
11-digit billing NDC 50111039803
NCPDP billing unit EA — each (per item)
RxCUI 905199, 905222, 905225, 905395
UNII FD171B778Y
UPC 0350111327016, 0350111398016, 0350111328013
Application # ANDA089097
SPL Set ID ddbbdb09-3202-42d7-bbb0-08331dde2f54
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 1990-09-30
Route ORAL
Dosage form TABLET
Substance HYDRALAZINE HYDROCHLORIDE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 36400010100305
GPI class hydrALAZINE HCl
GCN Seq No 000284
GCN 01241
HICL code 000089
Ingredient (HICL) Hydralazine Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4A
Therapeutic class — specific (HIC3) Antihypertensives, Vasodilators
AHFS code 24:08.16.00
AHFS class Direct Vasodilators
FDB label name HYDRALAZINE 10 MG TABLET
FDB brand name Hydralazine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000284
  • GCN: 01241
  • GPI-14 (Medi-Span): 36400010100305
  • HICL (First Databank): 000089
  • AHFS class code: 24:08.16.00
  • RxCUI (RxNorm): 905199
Why two NDCs? The FDA registers this code as 50111-398-03 — 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 → 50111-0398-03. 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

Label name HYDRALAZINE 10 MG TABLET Ingredient Hydralazine Hcl
📖 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 eaPer package
Retail pharmacies payNADAC · weekly $0.027 $27.00 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $0.1085 $108.50 / 1000 tablets
Medicare drug plans payPart D · Q2 2026 $0.0607 $60.70 / 1000 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.037 $0.027
▼ Down 26% over the last 24 months.
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 Per unit Per pack Marketing startMarketing endStatus
50111-0398-01 50111-398-01 100 TABLET in 1 BOTTLE $0.0270 / ea $2.70 1990-09-30 — Active
50111-0398-03 You're viewing this Main listing 1000 TABLET in 1 BOTTLE $0.0270 / ea $27.00 1990-09-30 — Active

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

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0270 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 62% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 tablet in 1 bottle.
How does this package differ from NDC 50111-0398-01?
Both are Hydralazine Hydrochloride 10 mg Tablet — the drug itself is identical. This page's package is the 1,000-count one, while NDC 50111-0398-01 is the 100 tablets package.
What NDC number is used to bill for this package of Hydralazine Hydrochloride 10 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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydralazine Hydrochloride 10 mg 00904-7447-61 Major 100 tablets $0.027 AA Availability likely —
Hydralazine Hydrochloride 10 mg 23155-0001-01 Heritage 100 tablets $0.027 — Discontinued —
Hydralazine Hydrochloride 10 mg 23155-0832-01 Heritage 100 tablets $0.027 AA Availability likely —
Hydralazine Hydrochloride 10 mg 31722-0519-01 Camber 100 tablets $0.027 AA Availability likely —
Hydralazine Hydrochloride 10 mgthis 50111-0398-03 Teva 1000 tablets $0.027 AA Availability likely —
Hydralazine Hydrochloride 10 mg 50228-0182-01 ScieGen 100 tablets $0.027 AA Availability likely —
Hydralazine Hydrochloride 10 mg 51079-0074-20 Mylan 100 tablets $0.027 AA Availability likely —
Hydralazine Hydrochloride 10 mg 60687-0811-01 American 100 tablets $0.027 AA Availability likely —
Hydralazine Hydrochloride 10 mg 62135-0579-12 Chartwell 120 tablets $0.027 — Availability likely —
HydrALAZINE Hydrochloride 10 mg 76282-0309-01 Exelan 100 tablets $0.027 — Availability likely —
Hydralazine Hydrochloride 10 mg 33342-0374-11 Macleods 100 tablets — — FDA listed —
Hydralazine Hydrochloride 10 mg 48433-0046-20 Safecor 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 63629-8493-01 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 63629-8494-01 Bryant 100 tablets — AA FDA listed —
HydrALAZINE Hydrochloride 10 mg 64380-0733-06 Strides 100 tablets — — FDA listed —
Hydralazine Hydrochloride 10 mg 67046-1520-03 Coupler 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 67046-1609-03 Coupler 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 67877-0293-01 Ascend 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 68071-2055-03 NuCare 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 68462-0341-01 Glenmark 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 70518-4022-00 REMEDYREPACK 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 71205-0091-30 Proficient 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 71335-1685-01 Bryant 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 71335-2307-01 Bryant 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 72162-1535-00 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 10 mg 77771-0182-01 Radha 100 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

🏛️
1990
On the market since
Sep 1990
📍
2026
Currently FDA-listed
36 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.

What it looks like

Color orange
ShapeRound
ImprintPLIVA;397
Size11 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.

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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

5 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

LabelerTeva Pharmaceuticals USA, Inc.
Application holderPLIVA INC
FDA applicationANDA089097 (ANDA)
Labeler code50111
First marketedSep 1990
Product typeHuman Prescription Drug
Portfolio504 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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 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 66 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 133 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.

🤰 Pregnancy 108 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C 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.

🧒 Pediatric Use 67 words ▾

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 in pediatric patients. The usual recommended oral starting dosage is 0.75 mg/kg of body weight daily in four divided doses. Dosage may be increased gradually over the next 3 to 4 weeks to a maximum of 7.5 mg/kg or 200 mg daily.

🆘 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 195 words ▾

HOW SUPPLIED Hydralazine Hydrochloride Tablets USP are available as: 10 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 398” on one side and plain on the other side. Available in bottles of 100 (NDC 50111-398-01) and 1000 (NDC 50111-398-03). 25 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 327” on one side and plain on the other side.

Available in bottles of 100 (NDC 50111-327-01) and 1000 (NDC 50111-327-03). 50 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 328” on one side and plain on the other side. Available in bottles of 100 (NDC 50111-328-01) and 1000 (NDC 50111-328-03).

100 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 397” on one side and plain on the other side. Available in bottles of 100 (NDC 50111-397-01). 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, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Czech Republic By: TEVA CZECH INDUSTRIES s.r.o.

Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. F 2/2016

📋 Description 103 words ▾

DESCRIPTION Hydralazine Hydrochloride Tablets 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 M.W. 196.64 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 anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Chem structure

💬 Information for Patients 22 words ▾

Information for Patients Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.

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

🍼 Nursing Mothers 12 words ▾

Nursing Mothers Hydralazine has been shown to be excreted in breast milk.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

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.

📄 Package Label / Principal Display Panel 140 words ▾

Package/Label Display Panel Hydralazine Hydrochloride Tablets USP 10 mg 100s Label Hydralazine Hydrochloride Tablets USP 10 mg 100s Label Text NDC 50111- 398 -01 HydrALAZINE Hydrochloride Tablets USP 10 mg Rx only 100 TABLETS TEVA

Package/Label Display Panel Hydralazine Hydrochloride Tablets USP 25 mg 100s Label Hydralazine Hydrochloride Tablets USP 25 mg 100s Label Text NDC 50111- 327 -01 HydrALAZINE Hydrochloride Tablets USP 25 mg Rx only 100 TABLETS TEVA

Package/Label Display Panel Hydralazine Hydrochloride Tablets USP 50 mg 100s Label Hydralazine Hydrochloride Tablets USP 50 mg 100s Label Text NDC 50111- 328 -01 HydrALAZINE Hydrochloride Tablets USP 50 mg Rx only 100 TABLETS TEVA

Package/Label Display Panel Hydralazine Hydrochloride Tablets USP 100 mg 100s Label Hydralazine Hydrochloride Tablets USP 100 mg 100s Label Text NDC 50111- 397 -01 HydrALAZINE Hydrochloride Tablets USP 100 mg Rx only 100 TABLETS TEVA

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
7.2K
Units reimbursed last 4 qtrs
670.8K
Gross reimbursed last 4 qtrs
$72.8K
Avg / prescription
$10.12
Avg / unit
$0.1085
Latest quarter Q1 2026
1.2KRx
Medicaid pays / ea
$0.1085
gross reimbursed
vs
NADAC / ea
$0.0270
acquisition cost
=
Spread
+$0.0815
+302% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
51% FFS 49% MCO
Fee-for-service · 3,699 Rx Managed care · 3,497 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 8,101 units · 104 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 7,072 units · 123 per 100k residents MN Wisconsin: 10,903 units · 184 per 100k residents WI Michigan: 23,205 units · 231 per 100k residents MI New York: 45,589 units · 233 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 11,804 units · 279 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 3,635 units · 396 per 100k residents SD Iowa: 2,398 units · 74.8 per 100k residents IA Illinois: 17,544 units · 140 per 100k residents IL Indiana: 12,368 units · 180 per 100k residents IN Ohio: 38,471 units · 326 per 100k residents OH Pennsylvania: 31,653 units · 244 per 100k residents PA New Jersey: 26,402 units · 284 per 100k residents NJ Massachusetts: 5,162 units · 73.7 per 100k residents MA California: 264,534 units · 679 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 953 units · 48.2 per 100k residents NE Missouri: 14,637 units · 236 per 100k residents MO Kentucky: 19,866 units · 439 per 100k residents KY West Virginia: 6,725 units · 380 per 100k residents WV Virginia: 16,347 units · 188 per 100k residents VA Maryland: 11,714 units · 190 per 100k residents MD Connecticut: 4,048 units · 112 per 100k residents CT Rhode Island: no data reported RI Arizona: 7,180 units · 96.6 per 100k residents AZ New Mexico: 1,455 units · 68.8 per 100k residents NM Kansas: no data reported KS Arkansas: 5,515 units · 180 per 100k residents AR Tennessee: 2,248 units · 31.5 per 100k residents TN North Carolina: 17,282 units · 160 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 4,230 units · 92.5 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 3,486 units · 31.6 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 14,254 units · 46.7 per 100k residents TX Florida: 32,051 units · 142 per 100k residents FL
Units reimbursed · per 100k residents
31.5679
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 679 /100k
2 Kentucky 439 /100k
3 South Dakota 396 /100k
4 West Virginia 380 /100k
5 Ohio 326 /100k
6 New Jersey 284 /100k
7 Oregon 279 /100k
8 Pennsylvania 244 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets this page50111-0398-03 7,196 Rx · $72,792
100 tablets50111-0398-01 4,446 Rx · $45,937
Drug total (last 4 qtrs): 11,642 Rx · 1,107,046 units · $118,729 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 50111-0397-01 · Teva 50111-0450-01 · Teva →
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.