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LABETALOL HYDROCHLORIDE 5 mg/mL Injection — NDC 83270-0179-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

LABETALOL HYDROCHLORIDE 5 mg/mL Injection — NDC 83270-179-01 (Billing 83270-0179-01)

by Onesource Specialty Pharma Limited · 1 VIAL, MULTI-DOSE in 1 CARTON / 40 mL in 1 VIAL, MULTI-DOSE

This is a package of LABETALOL HYDROCHLORIDE 5 mg/mL Injection from Onesource Specialty Pharma Limited, marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.

NDC 83270-0179-01
🏷️ FDA NDC (as labeled) 83270-179-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Labetalol Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 20, 2024 — Lack of Assurance of Sterility-The potential for incomplete crimp seals. (Pfizer Inc.) · FDA recall D-0565-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83270-179-01
Product NDC 83270-179
11-digit billing NDC 83270017901
RxCUI 896771
UNII 1GEV3BAW9J
UPC 0383270178014
Application # ANDA079134
SPL Set ID 6cb2c117-584c-4440-acfb-e4b1af4dc509
Established class (EPC) beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-27
Route INTRAVENOUS
Dosage form INJECTION
Substance LABETALOL HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 896771
Why two NDCs? The FDA registers this code as 83270-179-01 — 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 → 83270-0179-01. 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 beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker
Drug family (ATC) Alpha and beta blocking agents
How it works Adrenergic beta-Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Labetalol lowers blood pressure. The tablets are used for high blood pressure, and the IV form is used in the hospital for severe high blood pressure. Keeping blood pressure down r...
  • Take them by mouth, usually twice a day, as your prescriber directs. Food increases how much of the drug your body absorbs, so try to be consistent about taking it with or without...
  • Dizziness, nausea, tiredness and headache are the most common, and they often fade early in treatment. Standing up slowly helps with lightheadedness. Call your doctor if you get it...
  • Please don't stop suddenly. Stopping a beta blocker abruptly can worsen chest pain and, in some cases, lead to a heart attack. If you need to stop, your prescriber will lower the d...
📖 Read our full Labetalol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Labetalol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Labetalol nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83270-0179-01 You're viewing this Main listing 1 VIAL, MULTI-DOSE in 1 CARTON / 40 mL in 1 VIAL, MULTI-DOSE 2026-02-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
labetalol hydrochloride 5 mg/mL 25021-0317-20 Sagent 1 vial $0.185 AP Availability likely —
Labetalol Hydrochloride 5 mg/mL 72603-0146-01 NorthStar 1 vial $0.185 AP Availability likely —
Labetalol Hydrochloride 5 mg/mL 00143-9622-01 Hikma 1 vial $0.185 AP Availability likely —
Labetalol Hydrochloride 5 mg/mL 36000-0322-02 Baxter 1 vial $0.185 AP Availability likely —
Labetalol Hydrochloride 5 mg/mL 65145-0124-01 Caplin 1 vial $0.185 AP Availability likely —
Labetalol Hydrochloride 5 mg/mL 72572-0350-01 Civica, 1 vial $0.185 AP Availability likely —
Labetalol Hydrochloride 5 mg/mL 00143-9320-01 Hikma 1 vial $0.185 AP Availability likely —
Labetalol Hydrochloride 5 mg/mL 72266-0102-01 Fosun 1 vial $0.185 AP Availability likely —
Labetalol Hydrochloride 5 mg/mL 00409-2339-34 Hospira, 1 cartridge — AP FDA listed —
Labetalol Hydrochloride 5 mg/mL 00409-2267-20 Hospira, 1 vial — AP Discontinued —
Labetalol Hydrochloride 5 mg/mL 72266-0103-01 Fosun 1 vial — AP FDA listed —
Labetalol Hydrochloride 5 mg/mL 36000-0324-02 Baxter 1 vial — AP FDA listed —
Labetalol Hydrochloride 5 mg/mL 55154-4747-05 Cardinal 5 cartridges — AP FDA listed —
Labetalol Hydrochloride 5 mg/mL 68083-0111-01 Gland 10 vials — AP FDA listed —
Labetalol Hydrochloride 5 mg/mL 00409-0125-25 Hospira, 25 vials — AP FDA listed —
Labetalol Hydrochloride 5 mg/mL 00143-9623-01 Hikma 1 vial — AP FDA listed —
Labetalol Hydrochloride 5 mg/mL 65145-0125-01 Caplin 1 vial — AP FDA listed —
Labetalol Hydrochloride 5 mg/mL 36000-0320-10 Baxter 10 vials — AP FDA listed —
Labetalol Hydrochloride 5 mg/mL 70121-2428-03 Amneal 1 syringe — AP FDA listed —
Labetalol Hydrochloride 5 mg/mL 00143-9183-10 Hikma 10 vials — — FDA listed —
Labetalol Hydrochloride 5 mg/mL 83270-0178-01 Onesource 1 vial — — FDA listed —
Labetalol Hydrochloride 5 mg/mLthis 83270-0179-01 Onesource 1 vial — — 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
Feb 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.

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 5SL0G7R0OK
    A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

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 DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerOnesource Specialty Pharma Limited
Application holderONESOURCE SPECIALTY PTE LTD
FDA applicationANDA079134 (ANDA)
Labeler code83270
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio53 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

INDICATIONS AND USAGE Labetalol Hydrochloride Injection, USP is indicated for control of blood pressure in severe hypertension

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Labetalol hydrochloride injection is intended for IV use in hospitalized patients. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing. Patients should always be kept in a supine position during the period of IV drug administration.

A substantial fall in blood pressure on standing should be expected in these patients. The patient's ability to tolerate an upright position should be established before permitting any ambulation, such as using toilet facilities . Either of two methods of administration of labetalol hydrochloride injection may be used: a) repeated IV injection, or b) slow continuous infusion.

Repeated Intravenous Injection Initially, labetalol hydrochloride injection should be given in a 20 mg dose (which corresponds to 0.25 mg/kg for an 80 kg patient) by slow IV injection over a 2-minute period. Immediately before the injection and at 5 and 10 minutes after injection, supine blood pressure should be measured to evaluate response. Additional injections of 40 or 80 mg can be given at 10-minute intervals until a desired supine blood pressure is achieved or a total of 300 mg of labetalol HCl has been injected.

The maximum effect usually occurs within 5 minutes of each injection. Slow Continuous Infusion Labetalol hydrochloride injection is prepared for continuous IV infusion by diluting the vial contents with commonly used IV fluids (see below). Examples of two methods of preparing the infusion solution are: Add 40 mL of labetalol hydrochloride injection to 160 mL of a commonly used IV fluid such that the resultant 200 mL of solution contains 200 mg of labetalol HCl, 1 mg/mL.

The diluted solution should be administered at a rate of 2 mL/min to deliver 2 mg/min. Alternatively, add 40 mL of labetalol hydrochloride injection to 250 mL of a commonly used IV fluid. The resultant solution will contain 200 mg of labetalol HCl, approximately 2 mg/3 mL.

The diluted solution should be administered at a rate of 3 mL/min to deliver approximately 2 mg/min. The rate of infusion of the diluted solution may be adjusted according to the blood pressure response, at the discretion of the physician. To facilitate a desired rate of infusion, the diluted solution can be infused using a controlled administration mechanism, e.g., graduated burette or mechanically driven infusion pump.Since the half-life of labetalol is 5 to 8 hours, steady-state blood levels (in the face of a constant rate of infusion) would not be reached during the usual infusion time period.

The infusion should be continued until a satisfactory response is obtained and should then be stopped and oral labetalol HCl started (see below). The effective IV dose is usually in the range of 50 to 200 mg. A total dose of up to 300 mg may be required in some patients.

Blood Pressure Monitoring The blood pressure should be monitored during and after completion of the infusion or IV injection. Rapid or excessive falls in either systolic or diastolic blood pressure during IV treatment should be avoided. In patients with excessive systolic hypertension, the decrease in systolic pressure should be used as an indicator of effectiveness in addition to the response of the diastolic pressure.

Initiation of Dosing with Labetalol Tablets Subsequent oral dosing with labetalol tablets should begin when it has been established that the supine diastolic blood pressure has begun to rise. The recommended initial dose is 200 mg, followed in 6 to 12 hours by an additional dose of 200 or 400 mg, depending on the blood pressure response. Thereafter, inpatient titration with labetalol tablets may proceed as follows: Inpatient Titration Instructions Regimen Daily Dose * 200 mg b.i.d 400 mg 400 mg b.i.d 800 mg 800 mg b.i.d 1600 mg 1200 mg b.i.d 2400 mg * If needed, the total daily dose may be given in three divided doses.

The dosage of labetalol tablets used in the hospital may be increased at 1-day intervals to… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 65 words ▾

CONTRAINDICATIONS Labetalol hydrochloride injection is contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see WARNINGS ). Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

⚠️ Warnings ~3 min read ▾

Warnings Hepatic Injury Severe hepatocellular injury, confirrmed by rechallenge in at least one case, occurs rarely with labetalol therapy. The hepatic injury is usually reversible, but hepatic necrosis and death have been reported. Injury has occurred after both short- and long-term treatment and may be slowly progressive despite minimal symptomatology.

Similar hepatic events have been reported with a related compound, dilevalol HCl, including two deaths. Dilevalol HCl is one of the four isomers of labetalol HCl. Thus, for patients taking labetalol, periodic determination of suitable hepatic laboratory tests would be appropriate.

Laboratory testing should be done at the very first symptom or sign of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness, or unexplained “flu-like” symptoms). If the patient has laboratory evidence of liver injury or jaundice, labetalol should be stopped and not restarted. Cardiac Failure Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure.Beta-blockade carries a potential hazard of further depressing myocardial contractility and precipitating more severe failure.

Although beta-blockers should be avoided in overt congestive heart failure, if necessary, labetalol HCl can be used with caution in patients with a history of heart failure who are well compensated. Congestive heart failure has been observed in patients receiving labetalol HCl. Labetalol HCl does not abolish the inotropic action of digitalis on heart muscle.

In Patients without a History of Cardiac Failure In patients with latent cardiac insuffciency, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or be given a diuretic, and the response should be observed closely. If cardiac failure continues despite adequate digitalization and diuretic, therapy with labetalol hydrochloride should be withdrawn (gradually, if possible).

Ischemic Heart Disease Angina pectoris has not been reported upon labetalol HCl discontinuation. However, following abrupt cessation of therapy with some beta-blocking agents in patients with coronary artery disease, exacerbations of angina pectoris and, in some cases, myocardial infarction have been reported. Therefore,such patients should be cautioned against interruption of therapy without the physician's advice.

Even in the absence of overt angina pectoris, when discontinuation of labetalol hydrochloride injection is planned, the patient should be carefully observed and should be advised to limit physical activity. If angina markedly worsens or acute coronary insuffciency develops, administration of labetalol hydrochloride injection should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Nonallergic Bronchospasm (e.g., Chronic Bronchitis and Emphysema) Since labetalol hydrochloride injection at the usual IV therapeutic doses has not been studied in patients with nonallergic bronchospastic disease, it should not be used in such patients.

Pheochromocytoma Intravenous labetalol HCl has been shown to be effective in lowering blood pressure and relieving symptoms in patients with pheochromocytoma; higher than usual doses may be required. However, paradoxical hypertensive responses have been reported in a few patients with this tumour; therefore, use caution when administering labetalol HCl to patients with pheochromocytoma. Diabetes Mellitus and Hypoglycemia Beta-adrenergic blockade may prevent the appearance of premonitory signs and symptoms (e.g.,tachycardia) of acute hypoglycemia.

This is especially important with labile diabetics. Beta-blockade also reduces the release of insulin in response to hyperglycemia; it may therefore be necessary to adju… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Labetalol hydrochloride injection is usually well tolerated. Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require labetalol Hcl withdrawal.Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving labetalol hydrochloride injection. Moderate hypotension occurred in 1 of 100 patients while supine.

Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients. The following also were reported with labetalol hydrochloride injection with the incidence per 100 patients as noted: Cardiovascular System Ventricular arrhythmia in 1. Central and Peripheral Nervous Systems Dizziness in 9, tingling of the scalp/skin in 7, hypoesthesia (numbness) and vertigo in 1 each.

Gastrointestinal System Nausea in 13, vomiting in 4, dyspepsia and taste distortion in 1 each. Metabolic Disorders Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8 of 100 patients; these were associated with drops in blood pressure, generally in patients with prior renal insuffciency. Psychiatric Disorders Somnolence/yawning in 3.

Respiratory System Wheezing in 1. Skin Pruritus in 1. The incidence of adverse reactions depends upon the dose of labetalol HCl.

The largest experience is with oral labetalol HCl (see labetalol HCl tablet product information for details). Certain of the side effects increased with increasing oral dose, as shown in the following table that depicts the entire U.S. therapeutic trials data base for adverse reactions that are clearly or possibly dose related. Labetalol Daily Dose (mg) 200 300 400 600 800 900 1200 1600 2400 Number of patients 522 181 606 608 503 117 411 242 175 Dizziness (%) 2 3 3 3 5 1 9 13 16 Fatigue 2 1 4 4 5 3 7 6 10 Nausea <1 0 1 2 4 0 7 11 19 Vomitting 0 0 <1 <1 <1 0 1 2 3 Dyspepsia 1 0 2 1 1 0 2 2 4 Paresthesia 2 0 2 2 1 1 2 5 5 Nasal stuffiness 1 1 2 2 2 2 4 5 6 Ejaculation failure 0 2 1 2 3 0 4 3 5 Impotence 1 1 1 1 2 4 3 4 3 Edema 1 0 1 1 1 0 1 2 2 In addition, a number of other less common adverse events have been reported: Cardiovascular Hypotension, and rarely, syncope, bradycardia, heart block.

Liver and Biliary System Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests. Hypersensitivity Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions. The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl during investigational use and extensive foreign marketing experience.

Clinical Laboratory Tests Among patients dosed with labetalol hydrochloride tablets, there have been reversible increases of serum transaminases in 4% of patients tested and, more rarely, reversible increases in blood urea. To report SUSPECTED ADVERSE REACTIONS, contact Onesource at 1-888-217-8103 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🆘 Overdosage 215 words ▾

Overdosage Overdosage with labetalol HCl causes excessive hypotension that is posture sensitive and, sometimes, excessive bradycardia. Patients should be placed supine and their legs raised if necessary to improve the blood supply to the brain. If overdosage with labetalol HCl follows oral ingestion, gastric lavage or pharmacologically induced emesis (using syrup of ipecac) may be useful for removal of the drug shortly after ingestion.

The following additional measures should be employed if necessary: Excessive bradycardia —administer atropine or epinephrine. Cardiac failure —administer a digitalis glycoside and a diuretic. Dopamine or dobutamine may also be useful.

Hypotension—administer vasopressors, e.g., norepinephrine. There is pharmacologic evidence that norepinephrine may be the drug of choice. Bronchospasm —administer epinephrine and/or an aerosolized beta2-agonist.

Seizures —administer diazepam. In severe beta-blocker overdose resulting in hypotension and/or bradycardia, glucagon has been shown to be effective when administered in large doses (5 to 10 mg rapidly over 30 seconds, followed by continuous infusion of 5 mg/hr that can be reduced as the patient improves). Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol from the general circulation (<1%).

The oral LD50 value of labetalol HCl in the mouse is approximately 600 mg/kg and in the rat is greater than 2 g/kg. The IV LD50 in these species is 50 to 60 mg/kg.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Labetalol HCl combines both selective, competitive, alpha1-adrenergic blocking and nonselective, competitive, beta-adrenergic blocking activity in a single substance. In man, the ratios of alpha- to beta-blockade have been estimated to be approximately 1:3 and 1:7 following oral and IV administration, respectively. Beta2-agonist activity has been demonstrated in animals with minimal beta1-agonist (ISA) activity detected.

In animals, at doses greater than those required for alpha- or beta-adrenergic blockade, a membrane stabilizing effect has been demonstrated. Pharmacodynamics The capacity of labetalol HCl to block alpha receptors in man has been demonstrated by attenuation of the pressor effect of phenylephrine and by a significant reduction of the pressor response caused by immersing the hand in ice-cold water (“cold-pressor test”). Labetalol HCl's beta-receptor blockade in man was demonstrated by a small decrease in the resting heart rate, attenuation of tachycardia produced by isoproterenol or exercise, and by attenuation of the reflex tachycardia to the hypotension produced by amyl nitrite.

Beta2-receptor blockade was demonstrated by inhibition of the isoproterenol-induced fall in diastolic blood pressure. Both the alpha- and beta-blocking actions of orally administered labetalol HCl contribute to a decrease in blood pressure in hypertensive patients. Labetalol HCl consistently, in dose-related fashion, blunted increases in exercise-induced blood pressure and heart rate, and in their double product.

The pulmonary circulation during exercise was not affected by labetalol HCl dosing. Single oral doses of labetalol HCl administered to patients with coronary artery disease had no significant effect on sinus rate, intraventricular conduction, or QRS duration. The atrioventricular (A-V) conduction time was modestly prolonged in two of seven patients.

In another study, IV labetalol HCl slightly prolonged A-V nodal conduction time and atrial effective refractory period with only small changes in heart rate. The effects on A-V nodal refractoriness were inconsistent. Labetalol HCl produces dose-related falls in blood pressure without reflex tachycardia and without significant reduction in heart rate, presumably through a mixture of its alpha- and beta blocking effects.

Hemodynamic effects are variable, with small, nonsignificant changes in cardiac output seen in some studies but not others, and small decreases in total peripheral resistance. Elevated plasma renins are reduced. Doses of labetalol HCl that controlled hypertension did not affect renal function in mildly to severely hypertensive patients with normal renal function.

Due to the alpha 1 -receptor blocking activity of labetalol HCl, blood pressure is lowered more in the standing than in the supine position, and symptoms of postural hypotension can occur. During dosing with IV labetalol HCl, the contribution of the postural component should be considered when positioning the patients for treatment, and the patient should not be allowed to move to an erect position unmonitored until their ability to do so is established. In a clinical pharmacologic study in severe hypertensives, an initial 0.25 mg/kg injection of labetalol HCl administered to patients in the supine position decreased blood pressure by an average of 11/7 mmHg.

Additional injections of 0.5 mg/kg at 15-minute intervals up to a total cumulative dose of 1.75 mg/kg of labetalol HCl caused further dose-related decreases in blood pressure. Some patients required cumulative doses of up to 3.25 mg/kg. The maximal effect of each dose level occurred within 5 minutes.

Following discontinuation of IV treatment with labetalol HCl, the blood pressure rose gradually and progressively, approaching pretreatment baseline values within an average of 16 to 18 hours in the majority of patients. Similar results were obtained in the treatment of patients with severe hypertension who required urgent blood pressu… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 106 words ▾

How Supplied Labetalol Hydrochloride Injection, USP is supplied as follows Labetalol Hydrochloride Injection,USP (5mg per mL) NDC Strength Package Factor 83270-178-01 100 mg per 20 mL Multi-Dose Vial 1 vial per carton 83270-179-01 200 mg per 40 mL Multi-Dose Vial 1 vial per carton Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze. Protect from light. Retain in carton until time of use.

Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. Manufactured by: Onesource Specialty Pharma limited Sterile Product Division, Opp IIM, Bilekahalli, Bannerghatta Road, Bengaluru, Karnataka 560076, India (IND) Revised: February 2026

📋 Description 175 words ▾

DESCRIPTION Labetalol Hydrochloride Injection, USP is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta adrenergic receptor blocking actions in a single substance.Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino]ethyl]benzamide monohydrochloride, and it has the following structure: Labetalol HCl has the molecular formula C 19 H 24 N 2 O 3 HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs.

Dilevalol,the R, R stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous (IV) injection.

It has a pH range of 3.0 to 4.5. Each milliliter contains 5 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium; 0.8 mg of methylparaben and 0.1 mg propylparaben as preservatives; and anhydrous citric acid and sodium hydroxide, as necessary, to bring the solution into the pH range. api-image

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Impaired Hepatic Function: Labetalol injection should be used with caution in patients with impaired hepatic function since metabolism of the drug may be diminished. Hypotension: Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving labetalol injection. Therefore, the patient's ability to tolerate an upright position should be established before permitting any ambulation.

Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers (labetalol is an alpha/beta blocker). This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions.The patient's ophthalmologist should be prepared for possible modifications to the surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.

There does not appear to be benefit of stopping alpha-1 blocker therapy prior to cataract surgery. Following Coronary Artery Bypass Surgery: In one uncontrolled study, patients with low cardiac indices and elevated systemic vascular resistance following intravenous labetalol experienced significant declines in cardiac output with little change in systemic vascular resistance. One of these patients developed hypotension following labetalol treatment.Therefore, use of labetalol should be avoided in such patients.

High Dose Labetalol: Administration of up to 3 g/d as an infusion for up to 2 to 3 days has been anecdotally reported; several patients have experienced hypotension or bradycardia. Jaundice or Hepatic Dysfunction: ( see WARNINGS) . Information for Patients The following information is intended to aid in the safe and effective use of this medication.

It is not a disclosure of all possible adverse or intended effects. During and immediately following (for up to 3 hours) labetalol hydrochloride injection, the patient should remain supine. Subsequently, the patient should be advised on how to proceed gradually to become ambulatory and should be observed at the time of first ambulation.

When the patient is started on labetalol hydrochloride tablets following adequate control of blood pressure with labetalol hydrochloride injection, appropriate directions for titration of dosage should be provided (see DOSAGE AND ADMINISTRATION ). As with all drugs with beta-blocking activity, certain advice to patients being treated with labetalol HCl is warranted. While no incident of the abrupt withdrawal phenomenon (exacerbation of angina pectoris) has been reported with labetalol HCl, dosing with labetalol hydrochloride tablets should not be interrupted or discontinued without a physician's advice.

Patients being treated with labetalol hydrochloride tablets should consult a physician at any signs or symptoms of impending cardiac failure or hepatic dysfunction (see WARNINGS ). Also, transient scalp tingling may occur, usually when treatment with labetalol hydrochloride tablets is initiated (see ADVERSE REACTIONS ). Laboratory Tests Routine laboratory tests are ordinarily not required before or after IV labetalol HCl.

In patients with concomitant illnesses, such as impaired renal function, appropriate tests should be done to monitor these conditions. Drug Interactions Since labetalol hydrochloride injection may be administered to patients already being treated with other medications, including other antihypertensive agents, careful monitoring of these patients is necessary to detect and treat promptly any undesired effect from concomitant administration. In one survey, 2.3% of patients taking labetalol HCl orally in combination with tricyclic antidepressants experienced tre… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 4 words ▾

20-mL-vial-label 20-mL-carton-label 40-mL-vial-label 40-mL-carton-label

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

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