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HydrALAZINE Hydrochloride 100 mg Tablet, 100-count — NDC 76282-0312-01 package photo

HydrALAZINE Hydrochloride 100 mg Tablet, 100-count

by Exelan Pharmaceuticals Inc. · 100 TABLET in 1 BOTTLE (76282-312-01)
NDC 76282-0312-01
🏷️ FDA NDC (as labeled) 76282-312-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 76282-312-01
Product NDC 76282-312
11-digit billing NDC 76282031201
NCPDP billing unit EA — each (per item)
RxCUI 905199, 905222, 905225, 905395
UNII FD171B778Y
UPC 0376282309019, 0376282310015, 0376282311012, 0376282312019
Application # ANDA090255
SPL Set ID 811831f9-a844-463a-874d-fb8407659f0b
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 2016-05-20
Route ORAL
Dosage form TABLET
Substance HYDRALAZINE HYDROCHLORIDE
GPI-14 36400010100320
GPI class hydrALAZINE HCl
GCN Seq No 000285
GCN 01242
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 100 MG TABLET
FDB brand name Hydralazine Hcl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 76282-312-01 — 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 → 76282-0312-01. 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.

🏭 Manufacturer & labeler

LabelerExelan Pharmaceuticals Inc.
Application holderINVAGEN PHARMACEUTICALS INC
FDA applicationANDA090255 (ANDA)
Labeler code76282
First marketedMay 2016
Product typeHuman Prescription Drug
Portfolio88 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.

🩺 Clinical

Label name HYDRALAZINE 100 MG TABLET Ingredient Hydralazine Hcl
📗 Our plain-language guide HelloPharmacist
  • Hydralazine is used to treat high blood pressure (hypertension). The tablet form is taken at home on a daily schedule, while the injectable form is reserved for hospital use when b...
  • It works by relaxing the walls of your arteries, which allows them to widen. When arteries are wider, blood flows through them more easily and your blood pressure drops. It's not a...
  • How does hydralazine lower my blood pressure?
  • Common side effects include headache, nausea, a fast heartbeat, flushing, and dizziness — these often settle as your body adjusts or if your dose is tweaked. You should call your d...
📖 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.

💊 What it looks like

Color Orange
ShapeRound
ImprintIG;312
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.

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.

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.

💲 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 $0.075 $7.46 / 100 tablets
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 $6.07 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.088 $0.075
▼ Down 7% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydralazine Hydrochloride 100 mg 00904-7450-61 Major 100 tablets $0.075 AA Availability likely —
Hydralazine Hydrochloride 100 mg 23155-0835-01 Heritage 100 tablets $0.075 AA Availability likely —
Hydralazine Hydrochloride 100 mg 31722-0522-01 Camber 100 tablets $0.075 AA Availability likely —
Hydralazine Hydrochloride 100 mg 50111-0397-01 Teva 100 tablets $0.075 AA Availability likely —
Hydralazine Hydrochloride 100 mg 50228-0185-01 ScieGen 100 tablets $0.075 AA Availability likely —
Hydralazine Hydrochloride 100 mg 62135-0582-12 Chartwell 120 tablets $0.075 — Availability likely —
HydrALAZINE Hydrochloride 100 mg 64380-0736-06 Strides 100 tablets $0.075 — Availability likely —
Hydralazine Hydrochloride 100 mg 72241-0006-05 Modavar 100 tablets $0.075 AA Availability likely —
HydrALAZINE Hydrochloride 100 mgthis 76282-0312-01 Exelan 100 tablets $0.075 — 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 mg 67877-0290-01 Ascend 100 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.

⏳ Availability & generic status

🏛️
2016
On the market since
May 2016
📍
2026
Currently FDA-listed
10 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Hydralazine Hydrochloride — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease2,858
Acute Kidney Injury2,684
Renal Failure2,137
Fatigue1,631
Dyspnoea1,624
End Stage Renal Disease1,609
Diarrhoea1,500

Age at onset

Neonate144
Infant22
Child15
Adolescent25
Adult1,969
Elderly3,004

Reporter sex

29,962 reports
Male · 46%
Female · 54%
Unknown · 0%

Serious outcomes

Hospitalization12,795
Death3,674
Life-threatening1,403
Disabling680
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,454 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
76282-0312-01 You're viewing this 100 TABLET in 1 BOTTLE (76282-312-01) 2016-05-20 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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
🎯 Indications and Usage 11 words ▾

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

⏱️ Dosage and Administration 153 words ▾

2 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 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.

🆘 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 189 words ▾

HOW SUPPLIED HydrALAZINE Hydrochloride Tablets USP are available as: 10 mg - Orange, round, biconvex tablets debossed with 'IG' on one side and "309" on the other, supplied in bottles of 100 (NDC 76282-309-01) and 1000 (NDC 76282-309-10). 25 mg - Orange, round, biconvex tablets debossed with 'IG' on one side and "310" on the other, supplied in bottles of 100 (NDC 76282-310-01) and 1000 (NDC 76282-310-10). 50 mg - Orange, round, biconvex tablets debossed with 'IG' on one side and "311" on the other, supplied in bottles of 100 (NDC 76282-311-01) and 1000 (NDC 76282-311-10).

100 mg -Orange, round, biconvex tablets debossed with 'IG' on one side and "312" on the other, supplied in bottles of 100 (NDC 76282-312-01). 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 by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432 Rev: 06/20 Barcode: 312-06-2020 Rx only

📋 Description 96 words ▾

DESCRIPTION HydrALAZINE Hydrochloride Tablets 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, 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, lactose anhydrous, sodium starch glycolate, FD&C Yellow #6 and stearic acid.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76282-0311-01 · Exelan 76282-0321-01 · Exelan →
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.