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Hydralazine Hydrochloride 50 mg Tablet, 1,000-count — NDC 23155-0834-10 package photo

Hydralazine Hydrochloride 50 mg Tablet, 1,000-count

by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. · 1000 TABLET in 1 BOTTLE (23155-834-10)
NDC 23155-0834-10
🏷️ FDA NDC (as labeled) 23155-834-10 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.0445 NADAC Per package$44.50 / 1000 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1215/unit · Part D plans $0.0607/unit — full pricing hub ↓
Also comes in: 100 tablets 23155-0834-01
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 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) 23155-834-10
Product NDC 23155-834
11-digit billing NDC 23155083410
NCPDP billing unit EA — each (per item)
RxCUI 905199, 905222, 905225, 905395
UNII FD171B778Y
UPC 0323155834017, 0323155835014, 0323155833010, 0323155832013
Application # ANDA040858
SPL Set ID 669532c9-ba15-4f4b-95a8-13782deb3521
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 2023-08-02
Route ORAL
Dosage form TABLET
Substance HYDRALAZINE HYDROCHLORIDE
GPI-14 36400010100315
GCN Seq No 000287
GCN 01244
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 50 MG TABLET
FDB brand name Hydralazine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 23155-834-10 — 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 → 23155-0834-10. 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

LabelerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application holderHERITAGE PHARMACEUTICALS INC
FDA applicationANDA040858 (ANDA)
Labeler code23155
First marketedAug 2023
Product typeHuman Prescription Drug
Portfolio253 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 50 MG TABLET Ingredient Hydralazine Hcl
📗 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.

💊 What it looks like

Color pink
ShapeRound
ImprintEP;104
Size1 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 $0.045 $44.50 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $0.1215 $121.50 / 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 2024 Jan 2026 May 2026 Sep 2026 $0.051 $0.045
▼ Down 13% over the last 12 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 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 mgthis 23155-0834-10 Heritage 1000 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 31722-0521-01 Camber 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 50111-0328-01 Teva 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 50228-0184-01 ScieGen 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 51079-0076-20 Mylan 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 60687-0833-01 American 100 tablets $0.045 AA Availability likely —
Hydralazine Hydrochloride 50 mg 62135-0581-12 Chartwell 120 tablets $0.045 — Availability likely —
HydrALAZINE Hydrochloride 50 mg 64380-0735-06 Strides 100 tablets $0.045 — Availability likely —
HydrALAZINE Hydrochloride 50 mg 76282-0311-01 Exelan 100 tablets $0.045 — Availability likely —
Hydralazine Hydrochloride 50 mg 33342-0376-11 Macleods 100 tablets — — FDA listed —
Hydralazine Hydrochloride 50 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 50090-0139-00 A-S 100 tablets — AA Discontinued —
Hydralazine Hydrochloride 50 mg 50090-6608-00 A-S 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 50090-6684-00 A-S 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 50090-7210-01 A-S 60 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 50090-7212-00 A-S 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 51655-0916-26 Northwind 90 tablets — — Discontinued —
Hydralazine Hydrochloride 50 mg 55154-0187-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 55154-2140-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 55154-5085-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 63629-5246-01 Bryant 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 63629-8497-01 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 67046-1517-03 Coupler 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 67877-0291-01 Ascend 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 68071-1940-03 NuCare 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 68462-0343-01 Glenmark 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 70518-4007-00 REMEDYREPACK 30 tablets — AA FDA listed —
HydrALAZINE Hydrochloride 50 mg 71205-0072-30 Proficient 30 tablets — — FDA listed —
Hydralazine Hydrochloride 50 mg 71209-0017-05 Cadila 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 71335-9756-01 Bryant 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 71610-0562-60 Aphena 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 72162-1537-00 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 50 mg 72241-0005-05 Modavar 100 tablets — AA FDA listed —
Hydralazine 50 mg 75834-0127-00 Nivagen 1000 tablets — AA Discontinued —
Hydralazine Hydrochloride 50 mg 77771-0184-01 Radha 100 tablets — AA FDA listed —
HydrALAZINE Hydrochloride 50 mg 67046-2080-03 Coupler 30 tablets — — 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

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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.

🗺️ 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 23155-0834-10, 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
34.6K
Units reimbursed last 4 qtrs
3.1M
Gross reimbursed last 4 qtrs
$371.3K
Avg / prescription
$10.72
Avg / unit
$0.1215
Latest quarter Q1 2026
8.2KRx
Medicaid pays / ea
$0.1215
gross reimbursed
vs
NADAC / ea
$0.0445
acquisition cost
=
Spread
+$0.0770
+173% 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 ⓘ
46% FFS 54% MCO
Fee-for-service · 15,916 Rx Managed care · 18,721 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 33,554 units · 430 per 100k residents WA Idaho: 2,421 units · 123 per 100k residents ID Montana: no data reported MT North Dakota: 1,230 units · 157 per 100k residents ND Minnesota: 10,311 units · 180 per 100k residents MN Wisconsin: 32,795 units · 555 per 100k residents WI Michigan: 126,428 units · 1,260 per 100k residents MI New York: 670,974 units · 3,428 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 15,485 units · 366 per 100k residents OR Nevada: 18,533 units · 580 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 8,338 units · 260 per 100k residents IA Illinois: 248,757 units · 1,982 per 100k residents IL Indiana: 47,575 units · 693 per 100k residents IN Ohio: 112,884 units · 958 per 100k residents OH Pennsylvania: 85,219 units · 658 per 100k residents PA New Jersey: 132,893 units · 1,430 per 100k residents NJ Massachusetts: 8,602 units · 123 per 100k residents MA California: 354,169 units · 909 per 100k residents CA Utah: no data reported UT Colorado: 4,111 units · 69.9 per 100k residents CO Nebraska: 1,008 units · 51.0 per 100k residents NE Missouri: 83,302 units · 1,344 per 100k residents MO Kentucky: 80,991 units · 1,789 per 100k residents KY West Virginia: 22,123 units · 1,250 per 100k residents WV Virginia: 55,576 units · 638 per 100k residents VA Maryland: 104,607 units · 1,693 per 100k residents MD Connecticut: 47,047 units · 1,301 per 100k residents CT Rhode Island: 3,403 units · 311 per 100k residents RI Arizona: 19,219 units · 259 per 100k residents AZ New Mexico: 3,348 units · 158 per 100k residents NM Kansas: 13,345 units · 454 per 100k residents KS Arkansas: 8,598 units · 280 per 100k residents AR Tennessee: 40,180 units · 564 per 100k residents TN North Carolina: 117,047 units · 1,080 per 100k residents NC South Carolina: 15,257 units · 284 per 100k residents SC Delaware: 16,742 units · 1,624 per 100k residents DE Oklahoma: 13,740 units · 339 per 100k residents OK Louisiana: 25,338 units · 554 per 100k residents LA Mississippi: 16,453 units · 560 per 100k residents MS Alabama: 14,760 units · 289 per 100k residents AL Georgia: 25,874 units · 235 per 100k residents GA D.C.: 46,028 units · 6,779 per 100k residents DC Hawaii: no data reported HI Texas: 77,186 units · 253 per 100k residents TX Florida: 81,816 units · 362 per 100k residents FL
Units reimbursed · per 100k residents
51.06,779
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 D.C. 6,779 /100k
2 New York 3,428 /100k
3 Illinois 1,982 /100k
4 Kentucky 1,789 /100k
5 Maryland 1,693 /100k
6 Delaware 1,624 /100k
7 New Jersey 1,430 /100k
8 Missouri 1,344 /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 page23155-0834-10 34,637 Rx · $371,263
100 tablets23155-0834-01 27,385 Rx · $304,507
Drug total (last 4 qtrs): 62,022 Rx · 6,066,377 units · $675,770 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Per unit Per pack Marketing startStatus
23155-0834-01 100 TABLET in 1 BOTTLE (23155-834-01) $0.0445 / ea $4.45 2023-08-02 Active
23155-0834-10 You're viewing this 1000 TABLET in 1 BOTTLE (23155-834-10) $0.0445 / ea $44.54 2023-08-02 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 ($0.0445 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 56% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 23155-0834-10?
NDC 23155-0834-10 is a 1,000-count package — 1000 tablet in 1 bottle.
What is the difference between NDC 23155-0834-10 and NDC 23155-0834-01?
Both are Hydralazine Hydrochloride 50 mg Tablet — the drug itself is identical. NDC 23155-0834-10 is the 1,000-count package, while NDC 23155-0834-01 is the 100 tablets package.
What NDC number is used to bill for this package of Hydralazine Hydrochloride 50 mg Tablet?
Bill NDC 23155-0834-10 — the 11-digit billing format is 23155083410. 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.

📄 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 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.

🆘 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 183 words ▾

HOW SUPPLIED HydrALAZINE Hydrochloride Tablets, USP are available as: 10 mg – Round, peach core tablet, debossed EP on one side and 101 on the reverse side. NDC 23155-832-01 Bottles of 100 NDC 23155-832-10 Bottles of 1000 25 mg – Round, peach, core tablet, debossed EP over 102 on one side and plain on the reverse side. NDC 23155-833-01 Bottles of 100 NDC 23155-833-10 Bottles of 1000 50 mg – Round, peach, core tablet, debossed EP over 103 on one side and plain on the reverse side.

NDC 23155-834-01 Bottles of 100 NDC 23155-834-10 Bottles of 1000 100 mg – Round, Peach, core tablet, debossed EP over 104 on one side and plain on the reverse side. NDC 23155-835-01 Bottles of 100 Dispense in a tight, light-resistant container as defined in the USP. 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: Stallion Laboratories Private Limited Gallops Industrial Park-II, Ahmedabad-382110, Gujarat, India Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1-866-901-DRUG (3784) Revised: 06/2025 logo

📋 Description 98 words ▾

DESCRIPTION HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether.

It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain magnesium stearate, microcrystalline cellulose, orange lake blend, silicon dioxide, and sodium starch glycolate.

The orange lake blend consists of FD&C yellow #6. structure-image

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