FDA-filed SPL labeling · retrieved through openFDA

Labetalol

Labetalol is a blood pressure-lowering medication used to treat high blood pressure (hypertension), including severe hypertension requiring urgent control.

Brand names NormodyneTrandateLabetalol HCl in Sodium ChlorideLabetalol HCl in Dextrose
Drug class ⓘ Beta-adrenergic Blocker
Rx Forms 3 Routes Oral · Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 70 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveOct 7, 2024
Clinical labels in scope ⓘ70
AvailabilityRx
Earliest approval/marketing year ⓘ1984
FDA-listed product records ⓘ384
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026 🚨Recall on record
⭐ Labetalol at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Labetalol is a dual-action blood pressure medicine that lowers high blood pressure by relaxing blood vessels and calming the heart. The tablet form is for ongoing management of hypertension, while the intravenous injection is reserved for severe hypertension in a hospital. Never stop labetalol suddenly, watch for signs of liver problems, and keep all follow-up appointments so your doctor can monitor your response.
How we write & review this content — our editorial policy →

📖 Labetalol: Patient Information Guide

A plain-language walkthrough of Labetalol — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Labetalol is approved to lower blood pressure across several products and forms:

  • Labetalol HCL and Labetalol Hydrochloride tablets (oral) are indicated for the management of hypertension (high blood pressure) — used alone or in combination with diuretics
  • LABETALOL HCl, Labetalol HCl in Dextrose, Labetalol HCl in Sodium Chloride, and Labetalol Hydrochloride injections (intravenous) are indicated specifically for severe hypertension requiring rapid control in a hospital setting
  • Lowering blood pressure with labetalol reduces the risk of serious cardiovascular events, primarily stroke and heart attack
⚙️How it works▾

Labetalol blocks two sets of receptors simultaneously: alpha-1 receptors and beta receptors. Blocking alpha-1 receptors causes blood vessels to relax and widen, reducing the resistance the heart pumps against. Blocking beta receptors slightly slows the heart rate and reduces how hard the heart pumps. Together, these effects lower blood pressure without causing the reflex speeding of the heart that can happen with some other blood pressure medicines.

Because it blocks alpha-1 receptors, labetalol lowers blood pressure more when you are standing than when lying down. This means lightheadedness on standing can occur, particularly shortly after a dose change. The balance of alpha to beta blockade differs between the oral and intravenous routes, so the two forms have somewhat different hemodynamic profiles.

💊How it's taken▾

Labetalol is available as an oral tablet and as an intravenous injection — these two forms are used in very different situations and are not interchangeable.

  • Tablets (Labetalol HCL, Labetalol Hydrochloride): Taken by mouth, generally twice daily. Taking them with food increases absorption. Your doctor will start at a low dose and adjust gradually based on your blood pressure readings.
  • Injection (LABETALOL HCl, Labetalol HCl in Dextrose, Labetalol HCl in Sodium Chloride, Labetalol Hydrochloride): Given only intravenously in a hospital by healthcare professionals, either as repeated injections or a slow continuous infusion, with blood pressure monitored throughout.

Always follow your prescriber's specific instructions. Never adjust your dose or stop taking labetalol on your own.

🤒Side effects — in detail▾

Most side effects of labetalol are mild and tend to appear early in treatment. Common ones include:

  • Dizziness or lightheadedness, especially when standing up quickly
  • Fatigue or general tiredness
  • Nausea
  • Headache
  • Weakness
  • Vomiting
  • Tingling of the scalp or skin

Serious reactions — including liver injury (jaundice, dark urine, persistent appetite loss), signs of heart failure (worsening breathlessness), sudden severe low blood pressure, or severe low blood sugar — require prompt medical attention. Do not wait to contact your doctor if these occur.

⚠️Warnings & precautions▾
  • Liver damage: Labetalol can rarely cause serious liver injury, including liver failure and death. Watch for yellowing skin or eyes, dark urine, loss of appetite, right-sided abdominal pain, or flu-like symptoms. If these appear, stop labetalol and seek medical care immediately.
  • Do not stop suddenly: Abruptly stopping labetalol — especially with coronary artery disease — can trigger severe chest pain or heart attack. Always taper under medical supervision.
  • Heart failure: Labetalol can worsen heart failure in some patients. Report any new or worsening shortness of breath or swelling to your doctor.
  • Breathing problems: Labetalol should generally not be used in people with asthma or obstructive airway disease, as it can cause bronchospasm (airway tightening).
  • Diabetes: Labetalol can mask a fast heartbeat — one of the early warning signs of low blood sugar (hypoglycemia). Monitor blood sugar carefully and seek emergency help for severe hypoglycemia.
  • Postural hypotension: Blood pressure drops more when standing than lying down; lightheadedness or fainting can occur, especially 2–4 hours after a dose.
  • Surgery: Inform your anesthesiologist that you take labetalol — a dangerous interaction with certain anesthetics (notably halothane) can cause excessive blood pressure drops.
🔀What it interacts with▾

Several medicines and substances can interact with labetalol in clinically important ways:

  • Tricyclic antidepressants (e.g., amitriptyline) — may increase the risk of tremor when combined with labetalol
  • Cimetidine (heartburn medicine) — raises labetalol blood levels; dose adjustments may be needed
  • Halothane anesthesia — can cause an extreme drop in blood pressure when used with intravenous labetalol; your surgical team must be informed
  • Nitroglycerin — labetalol can amplify the blood pressure-lowering effect; extra monitoring is needed in patients with angina
  • Verapamil-type calcium channel blockers — additive effects on heart rate and blood pressure; use with caution
  • Digitalis glycosides (e.g., digoxin) — both slow heart conduction; combining them raises the risk of bradycardia (dangerously slow heart rate)
  • Beta-agonist bronchodilators (e.g., albuterol) — labetalol can reduce their effectiveness in people with breathing problems
  • Epinephrine (used for severe allergic reactions) — may be less effective in people on labetalol who have a history of severe allergic reactions

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not take labetalol if you have bronchial asthma or a history of obstructive airway disease — this is a strict contraindication
  • Do not take it if you have overt heart failure, cardiogenic shock, severe bradycardia, or greater-than-first-degree heart block
  • Tell your doctor if you have liver disease — labetalol can cause liver injury, and liver problems increase drug exposure in your body
  • Tell your doctor if you have diabetes — labetalol can hide early signs of low blood sugar
  • Tell your doctor if you have coronary artery disease — stopping labetalol suddenly is dangerous
  • Tell your doctor if you have a pheochromocytoma (a type of adrenal tumor) — labetalol can occasionally cause a paradoxical rise in blood pressure in these patients
  • Pregnancy: Labetalol crosses the placenta and has been associated with low blood pressure, slow heart rate, and low blood sugar in newborns. Use only if your doctor determines the benefit outweighs the risk.
  • Breastfeeding: Small amounts pass into breast milk; discuss the risk-benefit with your doctor
  • Children: Safety and effectiveness have not been established in pediatric patients
  • Older adults (60+): More likely to experience dizziness and lightheadedness when standing; take extra precautions to prevent falls
🚑If you take too much▾

Too much labetalol can cause a severe drop in blood pressure (especially when standing) and sometimes a dangerously slow heart rate. If an overdose is suspected, seek emergency medical care immediately — lie flat with legs elevated to help maintain blood flow to the brain. Dialysis does not effectively remove labetalol from the body, so hospital-based supportive treatment is essential.

📡Pharmacodynamics — effects in the body▾

Labetalol lowers blood pressure by simultaneously relaxing blood vessels (via alpha-1 blockade) and reducing the heart's workload (via beta blockade), producing a dose-related fall in blood pressure without a compensatory increase in heart rate. It also blunts the blood pressure and heart rate spikes caused by exercise. Blood pressure is lowered more when standing than when lying down because of the alpha-blocking effect, which can lead to lightheadedness on standing — most likely 2 to 4 hours after a dose.

🔬Pharmacokinetics — how your body processes it▾

After an oral dose, labetalol is fully absorbed from the gut, with peak blood levels reached within 1 to 2 hours. However, only about 25% of an oral dose reaches the bloodstream because of extensive first-pass metabolism in the liver — and taking it with food increases that amount. The drug has a half-life of about 6 to 8 hours after oral dosing, and steady blood levels are typically reached by the third day of regular dosing.

Labetalol is broken down mainly in the liver and excreted primarily through the urine. Liver impairment increases drug exposure. Neither hemodialysis nor peritoneal dialysis removes meaningful amounts of labetalol from the body. In older adults, elimination may be slower, generally meaning lower maintenance doses are needed.

📦How to store it▾

stored at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

📄 Written from Labetalol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

176

Supplements & herbs that interact with Labetalol

176 supplements and herbal products have documented interactions with Labetalol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 8
  • Moderate · 148
  • Minor · 20
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major AMERICAN MISTLETOE Major BEER Major INDIAN SNAKEROOT Major SIBERIAN COCKLEBUR Major TYRAMINE Major WINE Major +168 more
Every supplement checked against Labetalol — ranked by severity The full interaction hub: 8 major · 148 moderate · 20 minor · every one linked to its full report. Check Labetalol against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Labetalol has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

COENZYME Q10 Insufficient Evidence
See the full Labetalol nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Labetalol — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is labetalol used for? ▾
Labetalol is used to lower high blood pressure (hypertension). The tablet form is for ongoing daily management of hypertension, and can be used on its own or with other blood pressure medicines like diuretics. The intravenous injection form is used in hospitals specifically for severe hypertension that needs to be brought down quickly. By controlling blood pressure, labetalol helps reduce your risk of stroke and heart attack over time.
Is it okay to stop taking labetalol if I feel fine? ▾
Please don't stop labetalol on your own, even if you feel great — this is really important. Stopping suddenly, especially if you have coronary artery disease (even undiagnosed), can trigger serious chest pain or even a heart attack. If you and your doctor decide it's time to stop, the dose should be reduced gradually over one to two weeks with close monitoring. Always talk to your prescriber before making any changes.
I feel dizzy when I stand up after taking labetalol — is that normal? ▾
Yes, this is a known effect. Labetalol lowers blood pressure more when you're standing than lying down, which can cause lightheadedness when you get up quickly — especially 2 to 4 hours after a dose. It's usually more noticeable early in treatment or after a dose increase. Standing up slowly, sitting on the edge of the bed for a moment first, and staying well hydrated can help. If you actually faint or the dizziness is severe, let your doctor know right away.
What side effects should I actually watch out for? ▾
Most people find labetalol quite tolerable — fatigue, mild nausea, dizziness, and headache are the most common complaints, and they often ease up after the first few weeks. The side effect that really warrants a call to your doctor is any sign of liver trouble: yellowing of your skin or eyes, dark urine, persistent loss of appetite, or flu-like symptoms that don't go away. Also call right away if you notice worsening shortness of breath, chest pain, or if you have diabetes and experience severe low blood sugar.
Can I take labetalol if I'm pregnant or breastfeeding? ▾
Labetalol does cross the placenta, and babies born to mothers who took it have sometimes had low blood pressure, a slow heart rate, or low blood sugar at birth. That said, untreated high blood pressure in pregnancy carries its own serious risks, so your doctor may still prescribe it if the benefit outweighs the risk — this is a conversation to have openly with your healthcare team. If you're breastfeeding, very small amounts pass into breast milk, so again, discuss it with your doctor so you can make the best decision for you and your baby.
Are there medicines I should avoid while taking labetalol? ▾
A few interactions are worth knowing about. Cimetidine — a common over-the-counter heartburn medicine — can raise labetalol levels in your blood, so let your doctor know if you use it regularly. If you take digoxin or verapamil for your heart, combining them with labetalol can slow your heart rate more than intended. If you use a rescue inhaler (like albuterol) for asthma or COPD, labetalol can reduce how well it works. And if you're having surgery, be sure to tell your anesthesiologist you're on labetalol — it can interact with certain anesthetics and cause a large blood pressure drop.
Is Labetalol available over the counter? ▾
Labetalol is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Labetalol first available? ▾
Labetalol has been available in the United States since at least 1984, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Labetalol? ▾
Labetalol is supplied by 68 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, Remedyrepack Inc..

💬 Answers drafted from Labetalol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Labetalol supplement interactions176 checked — ranked by severity 🌿Drug & Supplement CheckerLabetalol vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Labetalol NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Labetalol comes

Labetalol is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Labetalol HCL and Labetalol Hydrochloride tablets are used to treat high blood pressure (hypertension)
  • Labetalol HCL and Labetalol Hydrochloride tablets may be used alone or combined with other blood pressure medicines, especially diuretics
Important instructions
  • Labetalol HCL and Labetalol Hydrochloride tablets are taken by mouth, typically twice daily
  • Taking labetalol tablets with food increases the amount the body absorbs
  • Dosage is individualized — your doctor will adjust your dose gradually based on your blood pressure response
  • Do not stop taking labetalol tablets suddenly without talking to your doctor first
Available strengths 4 strengths
100 mg 200 mg 300 mg 400 mg
300 FDA-listed product records ⓘ

Injection

Into a vein
Brands Labetalol HCl in Dextrose Labetalol HCl in Sodium Chloride
How this form is used
What it may be used for
  • LABETALOL HCl, Labetalol HCl in Dextrose, Labetalol HCl in Sodium Chloride, and Labetalol Hydrochloride injections are used to lower blood pressure in severe hypertension in hospitalized patients
Important instructions
  • LABETALOL HCl, Labetalol HCl in Dextrose, Labetalol HCl in Sodium Chloride, and Labetalol Hydrochloride injections are given only intravenously (into a vein) by healthcare professionals in a hospital
  • Patients must remain lying flat (supine) during intravenous administration — standing up can cause a significant blood pressure drop
  • Labetalol HCl in Dextrose and Labetalol HCl in Sodium Chloride are ready-to-use solutions and do not require further dilution; no other medications should be added to the bag
  • The ability to stand safely must be confirmed by hospital staff before the patient is allowed to get up after receiving the injection
Available strengths 4 strengths
1 mg/mL 5 mg/mL 100 mg/20 mL 200 mg/40 mL
66 FDA-listed product records ⓘ

Inhaler

Inhaled
Available strengths 3 strengths
200 mg 300 mg 400 mg
3 FDA-listed product records ⓘ

📊 Labetalol across the U.S. market

How Labetalol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3
Dose forms ⓘ
68
Manufacturers
4
Brand names
384
FDA-listed product records ⓘ
1984
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (15) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack24%
A-S Medication Solutions8%
Remedyrepack Inc.4%
Hikma Pharmaceuticals USA Inc.4%
Method Pharmaceuticals, LLC3%
Cardinal Health 107, LLC3%
Other makers54%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Labetalol is used

A general measure of how commonly Labetalol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Labetalol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

525,457
Medicaid prescriptions filled (Q1–Q4 2025)
$12.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Labetalol prescribed? Of the 1,597 medications we measure, Labetalol ranks #257 by Medicaid prescriptions — more than 84% of them.

Where Labetalol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #257 of 1,597
#252 Morphine 562,550 Rx #253 Chlorthalidone 561,590 Rx #254 Bisacodyl 542,387 Rx #255 Metronidazole Vaginal 541,965 Rx #256 Methotrexate 533,549 Rx #257 Labetalol 525,457 Rx #258 Propofol 520,319 Rx #259 Pioglitazone 511,848 Rx #260 Dextromethorphan / Gua... 511,044 Rx #261 Clobazam 496,684 Rx #262 Prednisolone Ophthalmi... 496,500 Rx

Utilization by Labetalol product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 200 mg oral tablet is the most-dispensed Labetalol product — about 43% of these Medicaid prescriptions.

labetalol hydrochloride 200 MG Oral Tablet Most dispensed

223,691 Medicaid prescriptions (Q1–Q4 2025) 43% of Labetalol prescriptions shown $5.2M gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 17 of 119 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896762

labetalol hydrochloride 100 MG Oral Tablet

213,237 Medicaid prescriptions (Q1–Q4 2025) 41% of Labetalol prescriptions shown $3.4M gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 18 of 129 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896758

labetalol hydrochloride 300 MG Oral Tablet

69,023 Medicaid prescriptions (Q1–Q4 2025) 13% of Labetalol prescriptions shown $2.1M gross reimbursement (before rebates) ≈ $30 per prescription (gross)

Summed across the 14 of 108 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896766

labetalol hydrochloride 5 MG/ML Injectable Solution

6,112 Medicaid prescriptions (Q1–Q4 2025) 1% of Labetalol prescriptions shown $429,472 gross reimbursement (before rebates) ≈ $70 per prescription (gross)

Summed across the 10 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896771

4 ML labetalol hydrochloride 5 MG/ML Cartridge

6,067 Medicaid prescriptions (Q1–Q4 2025) 1% of Labetalol prescriptions shown $257,381 gross reimbursement (before rebates) ≈ $42 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1234256

labetalol hydrochloride 400 MG Oral Tablet

4,838 Medicaid prescriptions (Q1–Q4 2025) <1% of Labetalol prescriptions shown $787,712 gross reimbursement (before rebates) ≈ $163 per prescription (gross)

Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 896983

4 ML labetalol hydrochloride 5 MG/ML Injection

2,489 Medicaid prescriptions (Q1–Q4 2025) <1% of Labetalol prescriptions shown $135,147 gross reimbursement (before rebates) ≈ $54 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2477889

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Labetalol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 62 of 409 listed Labetalol NDCs with Medicaid activity.

🔍 Compare Labetalol products

A representative set of FDA-listed product records for Labetalol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 384 products — FDA National Drug Code Directory. See every product, package size and price: browse all 384 Labetalol NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Labetalol RxCUI 6185 5 dose forms · 13 strengths
  2. Dose form (SCDF) Injectable Solution RxCUI 377107 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 5 MG/ML RxCUI 896771
  5. Dose form (SCDF) Prefilled Syringe RxCUI 2598342 No current FDA listing
    Clinical drug / strength (SCD) 2 ML labetalol hydrochloride 5 MG/ML RxCUI 2598343 4 ML labetalol hydrochloride 5 MG/ML RxCUI 2727439

Look up RxCUI 6185 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Normodyne Trandate Labetalol HCl in Sodium Chloride Labetalol HCl in Dextrose

🏭 Manufacturers & labelers

Bryant Ranch Prepack 85 A-S Medication Solutions 27 Remedyrepack Inc. 14 Hikma Pharmaceuticals USA Inc. 13 Method Pharmaceuticals, LLC 12 Cardinal Health 107, LLC 10 Marlex Pharmaceuticals Inc 9 Innogenix, Inc. 9 American Health Packaging 9 Baxter Healthcare Corporation 9 BluePoint Laboratories Inc. 9 Hospira, Inc. 8 Actavis Pharma, Inc. 7 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 7 Cadila Pharmaceuticals Limited 7 Advagen Pharma Ltd 7 Biocon Pharma Inc. 7 St. Mary's Medical Park Pharmacy 7 Unichem Pharmaceuticals (USA), Inc. 6 Major Pharmaceuticals 6 Zydus Lifesciences Limited 6 Zydus Pharmaceuticals USA Inc. 6 Golden State Medical Supply, Inc. 6 Fosun Pharma USA Inc. 6

…and 16 more on the FDA NDC directory.

RxNorm drug class

Labetalol 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

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 7, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Labetalol.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Labetalol after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
70
NDC products indexed
384
Distinct labelers/manufacturers represented
68
Linked representative label ⓘ
Marlex Pharmaceuticals Inc
Linked label effective
Oct 7, 2024
Composite sections available
18
Linked SPL Set ID
28c91727-e5a8-48b3-a4df-d7bec8feda40
Linked SPL Document ID
23e98950-6176-fa93-e063-6294a90a60a9
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 70 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Marlex Pharmaceuticals Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.