FDA-filed SPL labeling · retrieved through openFDA

Levalbuterol Oral Inhalation

Levalbuterol is an inhaled bronchodilator used to treat or prevent bronchospasm (sudden airway tightening) in people with reversible obstructive airway disease, such as asthma.

Brand names Xopenex HFAXopenexLevalbuterol tartrate HFA inhalation
Drug classes ⓘ Adrenergic Beta2-agonists
Rx Forms 2 Routes Respiratory (inhalation) · Oral
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 22 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 effectiveDec 1, 2022
Clinical labels in scope ⓘ22
AvailabilityRx
Earliest approval/marketing year ⓘ1999
FDA-listed product records ⓘ83
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Levalbuterol Oral Inhalation at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Levalbuterol oral inhalation is a fast-acting bronchodilator that helps open the airways during bronchospasm in people with asthma and similar conditions. Use it exactly as prescribed — overuse is dangerous, and needing it more often than usual means it's time to call your doctor. It works best as part of a complete asthma plan that may also include an anti-inflammatory inhaler.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Levalbuterol inhalation solution concentrate is for use with a nebulizer only — it must never be swallowed or injected. The concentrate form must be diluted with sterile normal saline before it is put into the nebulizer. Follow the instructions for use carefully. Using it the wrong way or in the wrong device could result in receiving the wrong amount of medicine.

Read the full warning on DailyMed →

📖 Levalbuterol Oral Inhalation: Patient Information Guide

A plain-language walkthrough of Levalbuterol Oral Inhalation — 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▾

Levalbuterol oral inhalation is used to treat or prevent bronchospasm — sudden, tight narrowing of the airways — in people with reversible obstructive airway disease.

  • Xopenex (levalbuterol HCl) inhalation solution concentrate is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease, including asthma
  • Levalbuterol inhalation solution is not indicated for children under 6 years of age — clinical trials in this age group did not show effectiveness and showed more asthma-related side effects
⚙️How it works▾

Levalbuterol targets beta-2 receptors on the smooth muscle that wraps around the airways. When it binds to these receptors, it sets off a chemical chain reaction inside the muscle cells that lowers calcium levels and prevents the muscles from contracting — so the airways relax and widen, making it easier to breathe. This effect works throughout the airways, from the main windpipe down to the smallest breathing tubes. Levalbuterol can also help block the release of substances from immune cells (mast cells) in the airways that would otherwise trigger further tightening.

Because there are also some beta receptors in the heart, levalbuterol — like all medicines in this class — can affect heart rate and blood pressure in some people, especially at higher doses.

💊How it's taken▾

Levalbuterol inhalation solution is breathed in through a nebulizer, typically three times a day. The concentrate form must always be diluted with sterile normal saline before use. It can be taken with or without food, since it is inhaled and not swallowed. Children ages 6–11 use a lower dose than adults and adolescents 12 and older — always follow your prescriber's specific instructions.

  • Adults and adolescents 12 and older: typically three times a day, every 6 to 8 hours
  • Children 6–11 years: typically three times a day at a lower dose than adults
  • Do not exceed the recommended dose
  • If a dose is missed, take it as soon as you remember — but if it is almost time for the next dose, skip the missed one and resume your regular schedule
🤒Side effects — in detail▾

The most commonly reported side effects with levalbuterol inhalation include:

  • Nervousness
  • Tremor (shakiness, especially in the hands)
  • Headache
  • Dizziness
  • Fast heartbeat (tachycardia)
  • Palpitations (awareness of your heartbeat)
  • Chest pain
  • Runny or stuffy nose
  • Increased cough
  • Nausea or upset stomach

Stop using the medicine and get medical help right away if you have sudden worsening of breathing after a dose, signs of a serious allergic reaction (hives, swelling, difficulty breathing), chest pain, or a very fast or irregular heartbeat.

⚠️Warnings & precautions▾
  • Paradoxical bronchospasm: In rare cases, levalbuterol can cause the airways to tighten suddenly right after use — the opposite of what it should do. This is life-threatening. Stop using it and seek emergency care immediately. It can happen on the very first use of a new vial.
  • Do not overuse: Fatalities have been reported with excessive use of inhaled medicines like levalbuterol. Never exceed the prescribed dose. Needing extra doses more often than usual means your asthma may be worsening — call your doctor.
  • Not a replacement for anti-inflammatory treatment: Levalbuterol opens the airways but does not reduce airway inflammation. Many people with asthma also need an inhaled corticosteroid. Using levalbuterol alone may not be enough to control asthma long-term.
  • Heart effects: This medicine can raise heart rate and blood pressure, and may cause ECG (heart rhythm) changes. Use with extra caution if you have any heart condition.
  • Low potassium (hypokalemia): Levalbuterol can temporarily lower potassium levels in the blood, which may affect heart rhythm. This is usually short-lived but important to monitor if you are also taking diuretics.
  • Blood sugar changes: This medicine can raise blood glucose — important to know if you have diabetes.
🔀What it interacts with▾

Levalbuterol can interact with several types of medicines. Tell your doctor and pharmacist about everything you take:

  • Other short-acting inhaled bronchodilators or epinephrine: Combining them increases the risk of heart side effects — avoid using together
  • Beta-blockers (e.g., metoprolol, propranolol, atenolol): These can block levalbuterol from working and may cause dangerous airway tightening in people with asthma — generally should not be used together
  • Diuretics (water pills, especially loop or thiazide types like furosemide or hydrochlorothiazide): Can worsen low potassium and heart rhythm changes caused by levalbuterol
  • Digoxin: Levalbuterol may lower blood levels of digoxin — monitoring is recommended
  • MAO inhibitors (e.g., phenelzine, selegiline) and tricyclic antidepressants (e.g., amitriptyline, nortriptyline): These intensify levalbuterol's effects on the cardiovascular system — use with extreme caution, and ideally wait 2 weeks after stopping these drugs before starting levalbuterol

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 use levalbuterol if you have ever had a serious allergic reaction (including hives, swelling, anaphylaxis, or bronchospasm) to levalbuterol, albuterol, or any ingredient in the product
  • Tell your doctor if you have a heart condition — including coronary artery disease, irregular heartbeat (arrhythmia), or high blood pressure — as levalbuterol can affect heart rate and rhythm
  • Tell your doctor if you have diabetes — this medicine can raise blood sugar levels
  • Tell your doctor if you have hyperthyroidism (an overactive thyroid) or a seizure disorder
  • Tell your doctor if you are pregnant — uncontrolled asthma in pregnancy carries risks for both mother and baby, and your doctor will help find the right balance; a pregnancy registry exists to monitor outcomes (1-877-311-8972)
  • Tell your doctor if you are breastfeeding — it is unknown whether levalbuterol passes into human milk
  • Levalbuterol inhalation solution is not approved for children under 6 years of age
  • Tell your doctor about all prescription and over-the-counter medicines, vitamins, and supplements you take
🚑If you take too much▾

Taking too much levalbuterol can cause exaggerated side effects, including rapid heart rate (up to 200 beats per minute), irregular heartbeat, seizures, very high or very low blood pressure, severe tremor, nervousness, headache, nausea, dizziness, and dangerously low potassium levels. In the most serious cases, cardiac arrest and death have been associated with overuse of inhaled sympathomimetic drugs. If you think you or someone else has used too much, call 911 or Poison Control immediately and stop using the medicine.

📡Pharmacodynamics — effects in the body▾

Levalbuterol produces measurable bronchodilation (airway opening) that can be detected within minutes of inhalation. In clinical studies in adults with asthma, all tested doses produced significantly more bronchodilation than placebo, as measured by improvement in lung function (FEV1 — the amount of air you can forcefully exhale in one second). The medicine also temporarily raises heart rate and blood glucose and lowers potassium levels in the blood; these changes are generally dose-related and tend to diminish with regular use over time. It also offers some protection against triggers that can cause the airways to tighten.

🔬Pharmacokinetics — how your body processes it▾

After inhalation, levalbuterol is absorbed into the bloodstream relatively quickly, with peak blood levels typically reached within about 12 minutes. The active form of the medicine (R-albuterol) has a half-life of roughly 3 to 4 hours in adults — meaning the body clears half of it in that time. It is primarily broken down in the gastrointestinal tract and liver, and most of it (80–100%) leaves the body through the kidneys in urine, either as unchanged drug or as a metabolite. In children ages 6–11, drug exposure (the total amount in the bloodstream) is somewhat higher than in adults at the same dose, which is why children use a lower dose.

📦How to store it▾

Store Levalbuterol Inhalation Solution USP in the protective foil pouch at 20° to 25°C (68° to 77°F) . Protect from light and excessive heat.

📄 Written from Levalbuterol Oral Inhalation’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 →

🩺 Pharmacist Counseling Corner

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

What exactly is levalbuterol used for? ▾
Levalbuterol is a rescue bronchodilator — it's used to quickly open up your airways when they tighten up, like during an asthma attack or a flare of bronchospasm. Xopenex inhalation solution is approved for adults, teens, and kids 6 and older with reversible obstructive airway disease, such as asthma. It's meant to relieve symptoms fast, not to control asthma day to day on its own.
How do I use the nebulizer solution correctly? ▾
The concentrate form has to be diluted with sterile normal saline before you put it in the nebulizer — never use it straight from the vial without diluting first. You then breathe the mist in through a mouthpiece or face mask connected to an air compressor. Don't mix it with other medicines in the nebulizer cup unless your doctor specifically tells you to, because compatibility hasn't been tested. Follow the instructions that came with your nebulizer and your prescription label.
What side effects should I expect, and which ones mean I should call the doctor? ▾
The most common ones are shakiness (tremor), nervousness, a faster heartbeat, headache, and dizziness — especially when you first start using it. These are usually mild and tend to ease up over time. But call your doctor right away if you notice chest pain, a very fast or pounding heartbeat, or if your breathing suddenly gets worse right after you use it. That last one — breathing getting worse after a dose — is a rare but serious reaction that means you need emergency care immediately.
If I need to use it more often than usual, can I just take extra doses? ▾
Please don't. Needing extra doses more than usual is actually a warning sign that your asthma may be getting worse, not a signal to use more medicine. Overuse of inhaled bronchodilators like this one has been linked to serious and even fatal outcomes. If your usual doses aren't holding you, call your doctor — your treatment plan may need to be adjusted, possibly with the addition of an anti-inflammatory medicine like an inhaled corticosteroid.
Can I use this medicine if I'm pregnant or breastfeeding? ▾
Talk to your doctor before making any changes. Uncontrolled asthma during pregnancy actually carries its own risks for both you and your baby, so stopping your asthma medicine without guidance isn't automatically safer. There's a pregnancy registry you can join to help track outcomes — your doctor can give you the contact information. For breastfeeding, it's not yet known whether levalbuterol passes into breast milk, so discuss the best approach with your prescriber.
Are there medicines I should avoid while using levalbuterol? ▾
Yes — a few important ones. Beta-blockers (often used for heart conditions or blood pressure) can actually block levalbuterol from working and may trigger dangerous airway tightening if you have asthma. Certain antidepressants — MAO inhibitors and tricyclic antidepressants — can amplify levalbuterol's effects on your heart and blood vessels, so they need to be used with extreme caution or avoided. Water pills (diuretics) can worsen low potassium levels when combined with levalbuterol. Always tell every doctor and pharmacist you see that you use this medicine.
Is Levalbuterol Oral Inhalation available over the counter? ▾
Levalbuterol Oral Inhalation 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 Levalbuterol Oral Inhalation first available? ▾
Levalbuterol Oral Inhalation has been available in the United States since at least 1999, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Levalbuterol Oral Inhalation? ▾
Levalbuterol Oral Inhalation is supplied by 27 manufacturers listed in the FDA NDC Directory, including Aurobindo Pharma Limited, Ritedose Pharmaceuticals, LLC, Amneal Pharmaceuticals of New York LLC.

💬 Answers drafted from Levalbuterol Oral Inhalation’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

🌿Drug & Supplement CheckerLevalbuterol Oral Inhalation vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Levalbuterol Oral Inhalation NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Levalbuterol Oral Inhalation comes

Levalbuterol Oral Inhalation is available in 2 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.

Inhalation solution (nebulizer)

Inhaled
Brands Xopenex
How this form is used
What it may be used for
  • Xopenex (levalbuterol HCl) inhalation solution concentrate is used to treat or prevent bronchospasm in adults, adolescents, and children 6 years and older with reversible obstructive airway disease
  • Xopenex inhalation solution is not approved for children under 6 years of age
Important instructions
  • Xopenex inhalation solution concentrate must be diluted with sterile normal saline before use in a nebulizer
  • Xopenex inhalation solution is administered using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
  • Xopenex inhalation solution is typically used three times a day — follow your prescriber's instructions for timing
  • Do not mix Xopenex inhalation solution with other medications in the nebulizer, as compatibility has not been established
Available strengths 4 strengths
0.31 mg/3 mL 0.63 mg/3 mL 1.25 mg/0.5 mL 1.25 mg/3 mL
65 FDA-listed product records ⓘ

Inhaler

By mouth
Brands Levalbuterol tartrate HFA inhalation Xopenex HFA
Available strengths 1 strength
45 mcg
8 FDA-listed product records ⓘ

📊 Levalbuterol Oral Inhalation across the U.S. market

How Levalbuterol Oral Inhalation 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.

2
Dose forms ⓘ
27
Manufacturers
6
Brand names
83
FDA-listed product records ⓘ
1999
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 (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Aurobindo Pharma Limited13%
Ritedose Pharmaceuticals, LLC11%
Amneal Pharmaceuticals of New York LLC7%
Burel Pharmaceuticals, LLC7%
Sun Pharmaceutical Industries, Inc.5%
Mylan Pharmaceuticals Inc.5%
Other makers52%

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

📈 How widely Levalbuterol Oral Inhalation is used

A general measure of how commonly Levalbuterol Oral Inhalation 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 Levalbuterol Oral Inhalation 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.

197,722
Medicaid prescriptions filled (Q1–Q4 2025)
$12.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Levalbuterol Oral Inhalation prescribed? Of the 1,596 medications we measure, Levalbuterol Oral Inhalation ranks #393 by Medicaid prescriptions — more than 75% of them.

Where Levalbuterol Oral Inhalation ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #393 of 1,596
#388 Fremanezumab-vfrm Inje... 205,598 Rx #389 Solifenacin 205,369 Rx #390 Water 204,877 Rx #391 Metformin / Sitaglipti... 203,107 Rx #392 Silver Sulfadiazine 202,248 Rx #393 Levalbuterol Oral Inha... 197,722 Rx #394 Hydromorphone Injectio... 195,712 Rx #395 Chlorpromazine 195,153 Rx #396 Amlodipine and Benazep... 194,518 Rx #397 Ticagrelor 190,826 Rx #398 Atogepant 190,760 Rx

Utilization by Levalbuterol Oral Inhalation 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 actuation / 0.045 mg/actuation metered dose inhaler is the most-dispensed Levalbuterol Oral Inhalation product — about 56% of these Medicaid prescriptions.

200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler Most dispensed

111,553 Medicaid prescriptions (Q1–Q4 2025) 56% of Levalbuterol Oral Inhalation prescriptions shown $7.7M gross reimbursement (before rebates) ≈ $69 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 745791

levalbuterol 0.21 MG/ML Inhalation Solution

43,477 Medicaid prescriptions (Q1–Q4 2025) 22% of Levalbuterol Oral Inhalation prescriptions shown $2.6M gross reimbursement (before rebates) ≈ $61 per prescription (gross)

Summed across the 6 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311286

levalbuterol 0.417 MG/ML Inhalation Solution

36,401 Medicaid prescriptions (Q1–Q4 2025) 18% of Levalbuterol Oral Inhalation prescriptions shown $2.1M gross reimbursement (before rebates) ≈ $57 per prescription (gross)

Summed across the 6 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 242754

levalbuterol 0.103 MG/ML Inhalation Solution

5,691 Medicaid prescriptions (Q1–Q4 2025) 3% of Levalbuterol Oral Inhalation prescriptions shown $298,052 gross reimbursement (before rebates) ≈ $52 per prescription (gross)

Summed across the 6 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349590

levalbuterol 2.5 MG/ML Inhalation Solution

600 Medicaid prescriptions (Q1–Q4 2025) <1% of Levalbuterol Oral Inhalation prescriptions shown $127,263 gross reimbursement (before rebates) ≈ $212 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1855389

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 Levalbuterol Oral Inhalation, 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 21 of 113 listed Levalbuterol Oral Inhalation NDCs with Medicaid activity.

🔍 Compare Levalbuterol Oral Inhalation products

A representative set of FDA-listed product records for Levalbuterol Oral Inhalation — 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 83 of 83 products — FDA National Drug Code Directory. See every product, package size and price: browse all 83 Levalbuterol Oral Inhalation 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) Levalbuterol Oral Inhalation RxCUI 237159 2 dose forms · 5 strengths
  1. Dose form (SCDF) Inhalation Solution RxCUI 2108209 In current FDA listings
    Clinical drug / strength (SCD) 0.103 MG/ML RxCUI 349590 0.21 MG/ML RxCUI 311286 0.417 MG/ML RxCUI 242754 2.5 MG/ML RxCUI 1855389

Look up RxCUI 237159 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

Xopenex HFA Xopenex Levalbuterol tartrate HFA inhalation

🏭 Manufacturers & labelers

Aurobindo Pharma Limited 11 Ritedose Pharmaceuticals, LLC 9 Amneal Pharmaceuticals of New York LLC 6 Burel Pharmaceuticals, LLC 6 Sun Pharmaceutical Industries, Inc. 4 Mylan Pharmaceuticals Inc. 4 Teva Pharmaceuticals USA, Inc. 4 Bryant Ranch Prepack 4 Akorn 4 Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. 3 NorthStar RxLLC 3 Prasco Laboratories 3 Proficient Rx LP 3 Lupin Pharmaceuticals, Inc. 2 Actavis Pharma, Inc. 2 NuCare Pharmaceuticals,Inc. 2 Sterling Pharma Solutions Limited 2 Redpharm Drug 2 Sunovion Pharmaceuticals Inc. 1 Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd. 1 A-S Medication Solutions 1 SICOR Societa' Italiana Corticosteroidi s.r.l. 1 Olon SpA 1 Fine Chemicals Corporation (PTY) Ltd. 1

…and 3 more on the FDA NDC directory.

RxNorm drug class

Levalbuterol Oral Inhalation belongs to the beta2-Adrenergic Agonist class.

Pharmacologic class beta2-Adrenergic Agonist
How it works Adrenergic beta2-Agonists

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 Dec 1, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Levalbuterol Oral Inhalation.
📈
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 Levalbuterol Oral Inhalation after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
22
NDC products indexed
83
Distinct labelers/manufacturers represented
27
Linked representative label ⓘ
Proficient Rx LP
Linked label effective
Dec 1, 2022
Composite sections available
25
Linked SPL Set ID
a469689a-e64e-4117-b94a-c8b730abda1a
Linked SPL Document ID
a790bb9c-91e9-4231-a093-4d3edbaf94fc
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 22 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.

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. Proficient Rx LP 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.