HomeNDC LookupIngredientsHydralazine Hydrochloride › 23155-0832-01
Hydralazine Hydrochloride 10 mg Tablet, 100-count — NDC 23155-0832-01 package photo

Hydralazine Hydrochloride 10 mg Tablet, 100-count

by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. · 100 TABLET in 1 BOTTLE (23155-832-01)
NDC 23155-0832-01
🏷️ FDA NDC (as labeled) 23155-832-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0271 NADAC Per package$2.71 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0797/unit · Part D plans $0.0607/unit — full pricing hub ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 23155-832-01
Product NDC 23155-832
11-digit billing NDC 23155083201
NCPDP billing unit EA — each (per item)
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 36400010100305
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
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 23155-832-01 — 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 → 23155-0832-01. 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

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 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 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 →
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.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII KO5GYV0DCB
    Microcrystalline cellulose is a purified plant fiber used as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and improves how the medicine breaks apart in your body.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.

6 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 DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $0.027 $2.71 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.0797 $7.97 / 100 tablets
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
Jan 2024 Jan 2026 Apr 2026 Aug 2026 $0.034 $0.027
▼ Down 20% over the last 11 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 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 mgthis 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 mg 50111-0398-01 Teva 100 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

🏛️
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 23155-0832-01, 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 – Q4 2025 · 4 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
17.8K
Units reimbursed last 4 qtrs
1.8M
Gross reimbursed last 4 qtrs
$145.4K
Avg / prescription
$8.18
Avg / unit
$0.0797
Latest quarter Q4 2025
3.7KRx
Medicaid pays / ea
$0.0797
gross reimbursed
vs
NADAC / ea
$0.0271
acquisition cost
=
Spread
+$0.0526
+194% 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
33% FFS 67% MCO
Fee-for-service · 5,860 Rx Managed care · 11,913 Rx
State Medicaid map
Alaska: no data reported AK Maine: 19,921 units · 1,428 per 100k residents ME Washington: 50,244 units · 643 per 100k residents WA Idaho: 4,759 units · 242 per 100k residents ID Montana: 2,454 units · 217 per 100k residents MT North Dakota: no data reported ND Minnesota: 28,054 units · 489 per 100k residents MN Wisconsin: 46,168 units · 781 per 100k residents WI Michigan: 52,739 units · 525 per 100k residents MI New York: 172,573 units · 882 per 100k residents NY Vermont: no data reported VT New Hampshire: 7,062 units · 504 per 100k residents NH Oregon: 28,322 units · 669 per 100k residents OR Nevada: 16,069 units · 503 per 100k residents NV Wyoming: no data reported WY South Dakota: 942 units · 103 per 100k residents SD Iowa: 14,320 units · 447 per 100k residents IA Illinois: 106,525 units · 849 per 100k residents IL Indiana: 64,269 units · 937 per 100k residents IN Ohio: 69,524 units · 590 per 100k residents OH Pennsylvania: 82,324 units · 635 per 100k residents PA New Jersey: 35,422 units · 381 per 100k residents NJ Massachusetts: 92,694 units · 1,324 per 100k residents MA California: 52,551 units · 135 per 100k residents CA Utah: 5,984 units · 175 per 100k residents UT Colorado: 17,010 units · 289 per 100k residents CO Nebraska: 9,447 units · 478 per 100k residents NE Missouri: 58,998 units · 952 per 100k residents MO Kentucky: 71,620 units · 1,582 per 100k residents KY West Virginia: 34,114 units · 1,927 per 100k residents WV Virginia: 103,569 units · 1,188 per 100k residents VA Maryland: 46,733 units · 756 per 100k residents MD Connecticut: 42,572 units · 1,177 per 100k residents CT Rhode Island: 9,996 units · 913 per 100k residents RI Arizona: 33,629 units · 453 per 100k residents AZ New Mexico: 11,845 units · 560 per 100k residents NM Kansas: 6,003 units · 204 per 100k residents KS Arkansas: 15,024 units · 490 per 100k residents AR Tennessee: 37,009 units · 519 per 100k residents TN North Carolina: 93,742 units · 865 per 100k residents NC South Carolina: 30,393 units · 566 per 100k residents SC Delaware: 7,886 units · 765 per 100k residents DE Oklahoma: 32,054 units · 791 per 100k residents OK Louisiana: 31,123 units · 680 per 100k residents LA Mississippi: 12,040 units · 410 per 100k residents MS Alabama: 19,933 units · 390 per 100k residents AL Georgia: 38,971 units · 353 per 100k residents GA D.C.: 5,876 units · 865 per 100k residents DC Hawaii: no data reported HI Texas: 42,889 units · 141 per 100k residents TX Florida: 30,498 units · 135 per 100k residents FL
Units reimbursed · per 100k residents
1031,927
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 West Virginia 1,927 /100k
2 Kentucky 1,582 /100k
3 Maine 1,428 /100k
4 Massachusetts 1,324 /100k
5 Virginia 1,188 /100k
6 Connecticut 1,177 /100k
7 Missouri 952 /100k
8 Indiana 937 /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.
100 tablets this page23155-0832-01 17,773 Rx · $145,389
1000 tablets23155-0832-10 4,936 Rx · $44,134
Drug total (last 4 qtrs): 22,709 Rx · 2,174,607 units · $189,523 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
23155-0832-01 You're viewing this 100 TABLET in 1 BOTTLE (23155-832-01) $0.0271 / ea $2.71 2023-08-02 Active
23155-0832-10 1000 TABLET in 1 BOTTLE (23155-832-10) $0.0271 / ea $27.09 2023-08-02 Active

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0271 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 78% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 23155-0832-01?
NDC 23155-0832-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 23155-0832-01 and NDC 23155-0832-10?
Both are Hydralazine Hydrochloride 10 mg Tablet — the drug itself is identical. NDC 23155-0832-01 is the 100-count package, while NDC 23155-0832-10 is the 1000 tablets package.
What NDC number is used to bill for this package of Hydralazine Hydrochloride 10 mg Tablet?
Bill NDC 23155-0832-01 — the 11-digit billing format is 23155083201. 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 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 ↗
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.