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HydrALAZINE Hydrochloride 50 mg Tablet, 30-count

by Coupler LLC · 30 TABLET in 1 BLISTER PACK (67046-2080-3)
NDC 67046-2080-03
🏷️ FDA NDC (as labeled) 67046-2080-3 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 27, 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) 67046-2080-3
Product NDC 67046-2080
11-digit billing NDC 67046208003
RxCUI 905395
UNII FD171B778Y
Application # ANDA200770
SPL Set ID 58773e8c-b6bc-6bc6-e063-6294a90adc26
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 2026-08-07
Route ORAL
Dosage form TABLET
Substance HYDRALAZINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 67046-2080-3 — a 5-4-1 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 package segment → 67046-2080-03. 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.

🏭 Manufacturer & labeler

LabelerCoupler LLC
Application holderSTRIDES PHARMA GLOBAL PTE LTD
FDA applicationANDA200770 (ANDA)
Labeler code67046
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio465 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

📗 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.

🧪 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.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 50 mg 50111-0328-01 Teva 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 50228-0184-01 ScieGen 100 tablets $0.045 AA Availability likely —
HydrALAZINE Hydrochloride 50 mg 76282-0311-01 Exelan 100 tablets $0.045 — Availability likely —
Hydralazine Hydrochloride 50 mg 23155-0834-01 Heritage 100 tablets $0.045 AA Availability likely —
HydrALAZINE Hydrochloride 50 mg 64380-0735-06 Strides 100 tablets $0.045 — Availability likely —
Hydralazine Hydrochloride 50 mg 60687-0833-01 American 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 62135-0581-12 Chartwell 120 tablets $0.045 — Availability likely —
Hydralazine Hydrochloride 50 mg 00904-7449-61 Major 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 23155-0003-01 Heritage 100 tablets $0.045 — Availability likely —
Hydralazine Hydrochloride 50 mg 51079-0076-20 Mylan 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 31722-0521-01 Camber 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 67877-0291-01 Ascend 100 tablets — AA FDA listed —
HydrALAZINE Hydrochloride 50 mg 71205-0072-30 Proficient 30 tablets — — FDA listed —
Hydralazine 50 mg 75834-0127-00 Nivagen 1000 tablets — AA Discontinued —
Hydralazine Hydrochloride 50 mg 77771-0184-01 Radha 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 50090-6608-00 A-S 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 63629-8497-01 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 71209-0017-05 Cadila 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 71335-9756-01 Bryant 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 50090-7212-00 A-S 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 51655-0916-26 Northwind 90 tablets — — Discontinued —
Hydralazine Hydrochloride 50 mg 63629-5246-01 Bryant 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 71610-0562-60 Aphena 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 72241-0005-05 Modavar 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 43063-0392-90 PD-Rx 90 tablets — — FDA listed —
Hydralazine Hydrochloride 50 mg 48433-0048-20 Safecor 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 50090-7210-01 A-S 60 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 67046-1517-03 Coupler 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 68462-0343-01 Glenmark 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 72162-1537-00 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 55154-2140-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 33342-0376-11 Macleods 100 tablets — — FDA listed —
Hydralazine Hydrochloride 50 mg 50090-6684-00 A-S 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 55154-0187-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 70518-4007-00 REMEDYREPACK 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 68071-1940-03 NuCare 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 55154-5085-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 50090-0139-00 A-S 100 tablets — AA Discontinued —
HydrALAZINE Hydrochloride 50 mgthis 67046-2080-03 Coupler 30 tablets — — FDA listed —
Hydralazine Hydrochloride 50 mg 55154-0287-00 Cardinal 10 tablets — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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
67046-2080-03 You're viewing this 30 TABLET in 1 BLISTER PACK (67046-2080-3) 2026-08-07 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 67046-2080-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 67046-2080-03, written without dashes as 67046208003. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 67046-2080-03, the first segment (67046) is the labeler code FDA assigned to Coupler LLC; the middle segment (2080) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Coupler LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Coupler 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.

📄 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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 10 words ▾

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

⏱️ Dosage and Administration 155 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, USP. In a few resistant patients, up to 300 mg of hydrALAZINE hydrochloride tablets, USP daily may be required for a significant antihypertensive effect.

In such cases, a lower dosage of hydrALAZINE hydrochloride tablets, USP 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 157 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.

Call your doctor for medical advice about side effects. You may report side effects to Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com

🤰 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 ~1 min read ▾

HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP are supplied as: 10 mg 100 tablets in a HDPE bottle NDC: 64380-733-06 Orange colored, circular, biconvex tablets, debossed "10" on one side and plain on other side. 500 tablets in a HDPE bottle NDC: 64380-733-07 1000 tablets in a HDPE bottle NDC: 64380-733-08 25 mg 100 tablets in a HDPE bottle NDC: 64380-734-06 Orange colored circular, flat bevel edged tablets debossed "25" on one side & plain on other side 500 tablets in a HDPE bottle NDC: 64380-734-07 1000 tablets in a HDPE bottle NDC: 64380-734-08 50 mg 100 tablets in a HDPE bottle NDC: 64380-735-06 Orange colored circular, flat bevel edged tablets debossed "50" on one side & plain on other side 500 tablets in a HDPE bottle NDC: 64380-735-07 1000 tablets in a HDPE bottle NDC: 64380-735-08 100 mg 100 tablets in a HDPE bottle NDC: 64380-736-06 Orange colored circular, flat bevel edged tablets debossed "100" on one side & plain on other side 500 tablets in a HDPE bottle NDC: 64380-736-07 1000 tablets in a HDPE bottle NDC: 64380-736-08 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

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: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc.

Bridgewater, NJ 08807 Revised: 09/2025

📋 Description 128 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 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. 25 mg, 50 mg or 100 mg tablets also contain Anhydrous Lactose, Microcrystalline Cellulose, Sodium Starch Glycolate, Stearic Acid and Sunset Yellow Lake and 10 mg tablets contain Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Sodium Starch Glycolate, and Sunset Yellow Lake.

💬 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 67046-2073-03 · Coupler 67046-2083-03 · Coupler →
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.