FDA-filed SPL labeling · retrieved through openFDA

Budesonide

Budesonide inhalation suspension is an inhaled steroid used to control and prevent asthma symptoms in young children.

Brand names Entocort ECTarpeyoUcerisRhinocortOrtikos +7 more
Drug class Corticosteroid
Rx/OTC Forms 7 Routes Respiratory (inhalation) · Nasal · Oral · Rectal
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 33 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 effectiveJun 10, 2026
Clinical labels in scope 33
AvailabilityRx/OTC
Earliest approval/marketing year 1993
FDA-listed product records 217
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026 🚨Recall on record · 3
Other forms & routes:
Budesonide at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Budesonide inhalation suspension is a safe and effective daily controller medication for asthma in young children — but it is not a rescue treatment. Used consistently with the right nebulizer equipment, it reduces airway inflammation and helps prevent asthma flare-ups. Rinse your child's mouth after every dose, keep all follow-up appointments so their growth and overall health can be monitored, and always have a separate fast-acting inhaler on hand for sudden symptoms.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

This medication must only be inhaled using a jet nebulizer connected to an air compressor — it must never be swallowed. Using the wrong type of nebulizer (such as an ultrasonic nebulizer) will not deliver the medication correctly and could be harmful. Always confirm you are using the right equipment before each treatment.

Read the full warning on DailyMed →

📖 Budesonide: Patient Information Guide

A plain-language walkthrough of Budesonide — 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

Budesonide inhalation suspension is used to control asthma and prevent symptoms in young children. It is approved for:

  • Maintenance (daily long-term control) treatment of asthma in children 12 months to 8 years of age
  • Prophylactic (preventive) therapy to reduce the frequency and severity of asthma episodes

It is not indicated for relieving a sudden asthma attack (acute bronchospasm).

⚙️How it works

Budesonide is a potent inhaled corticosteroid (steroid) that works by binding to glucocorticoid receptors directly in the airway lining. This reduces the inflammation that causes airways to swell, tighten, and overreact — the root cause of most asthma symptoms. Because it acts locally in the lungs and is extensively broken down by the liver if absorbed, it delivers strong anti-inflammatory effects with relatively limited whole-body steroid exposure.

Improvement in asthma control can begin within 2 to 8 days of starting treatment, but the full benefit may take up to 4 to 6 weeks to develop.

💊How it's taken

Budesonide inhalation suspension is given by inhalation through a jet nebulizer connected to an air compressor, using a mouthpiece or face mask. It is typically given once or twice daily; the frequency and total daily amount depend on what asthma treatments the child was on before. Once asthma is stable, the prescriber will aim to use the lowest effective dose.

  • Use only a jet nebulizer — not an ultrasonic nebulizer
  • Do not swallow the liquid
  • Rinse your child's mouth with water after each treatment
  • If a dose is missed, give it as soon as remembered — but do not double up; follow your prescriber's guidance
🤒Side effects — in detail

The most commonly reported side effects in clinical trials included:

  • Respiratory infections and viral illnesses
  • Runny nose (rhinitis)
  • Coughing
  • Ear infections (otitis media)
  • Stomach upset, vomiting, or diarrhea
  • Mouth or throat yeast infection (thrush)
  • Nosebleeds
  • Eye redness (conjunctivitis) or rash

More serious reactions — including a severe allergic reaction, worsening breathing right after use, or signs of adrenal suppression — require immediate medical attention. Call your doctor or go to the ER if any of these occur.

⚠️Warnings & precautions
  • Not for acute attacks: This is a controller medication only. Never use it to treat a sudden asthma episode.
  • Adrenal suppression: Long-term steroid use can reduce the body's own steroid production. This is especially risky during illness or physical stress. Children coming off oral steroids must be tapered slowly.
  • Immune suppression: Budesonide can reduce the body's ability to fight infections. Chickenpox and measles can be more severe — contact a doctor immediately if exposure occurs.
  • Mouth/throat yeast infections: Can develop with inhaled steroid use. Rinsing the mouth after every dose reduces this risk.
  • Growth in children: Long-term use may slow growth rate. The prescriber should monitor height regularly.
  • Bone density: Extended use may reduce bone mineral density. Children with risk factors should be monitored.
  • Eye problems: Glaucoma (increased eye pressure) and cataracts (clouding of the eye lens) have been associated with inhaled steroid use. Regular eye check-ups are recommended.
  • Paradoxical bronchospasm: If breathing suddenly gets worse right after a dose, stop the medication and seek care.
🔀What it interacts with

Budesonide is broken down in the body by a liver enzyme called CYP3A4. Drugs that block this enzyme can raise budesonide levels in the blood and increase steroid side effects. Key interactions include:

  • Strong CYP3A4 inhibitors — including ritonavir, ketoconazole, itraconazole, clarithromycin, nefazodone, and several HIV medications (atazanavir, indinavir, nelfinavir, saquinavir, telithromycin) — can significantly increase budesonide exposure in the body; use with caution and inform your prescriber of all medications

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
  • Allergy: Do not use if your child has had an allergic reaction to budesonide or any ingredient in the suspension
  • Acute asthma / status asthmaticus: Contraindicated as primary treatment for sudden, severe asthma requiring emergency care
  • Active infections: Use with caution in children with tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye
  • Chickenpox / measles: Unvaccinated or non-immune children are at higher risk for severe illness while on inhaled steroids — inform the doctor of any exposure
  • Switching from oral steroids: The transition must be done slowly under medical supervision to avoid adrenal crisis
  • Bone density risk factors: Tell the doctor if there is a family history of osteoporosis or other bone health concerns
  • Eye conditions: Inform the prescriber of any history of glaucoma or cataracts
  • Pregnancy: Pregnant women with asthma should discuss continued use with their doctor — poorly controlled asthma carries its own risks to mother and baby
🚑If you take too much

The risk of acute toxicity from a single large inhaled dose is low. However, if budesonide is used in very high doses over a long period of time, it can cause signs of excess steroid in the body — such as adrenal suppression (the body's own steroid production shutting down) or growth suppression in children. If you are concerned about an overdose or accidental ingestion, contact your doctor or a poison control center.

📡Pharmacodynamics — effects in the body

Budesonide works primarily by acting directly on the lining of the airways — not by being absorbed into the bloodstream. This local anti-inflammatory action is what makes it effective for asthma control. Studies confirm that inhaled budesonide works in the lungs specifically, since oral budesonide (even at higher blood levels) did not produce the same benefit. It also reduces airway hyperresponsiveness — meaning the airways become less likely to overreact to triggers like allergens.

🔬Pharmacokinetics — how your body processes it

When inhaled, budesonide acts mainly in the lungs; any portion swallowed is mostly broken down by the liver on its first pass through (85–95% first-pass elimination), so very little reaches the rest of the body. It binds strongly to proteins in the blood (about 85–90%) and is cleared through metabolism, primarily via the CYP3A4 liver enzyme into inactive metabolites. This combination of local action and rapid liver clearance is what keeps systemic steroid exposure relatively low at normal doses.

📦How to store it

stored upright at controlled room temperature 20 to 25°C (68 to 77°F) , and protected from light. Keep out of reach of children. Do not freeze.

📄 Written from Budesonide’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 →

154

Supplements & herbs that interact with Budesonide

154 supplements and herbal products have documented interactions with Budesonide 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 · 4
  • Moderate · 110
  • Minor · 40
Every supplement checked against Budesonide — ranked by severity The full interaction hub: 4 major · 110 moderate · 40 minor · every one linked to its full report. Check Budesonide 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.

8

Nutrient depletion considerations

Budesonide has been associated with lower levels of 8 nutrients 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.

Evidence & significance mix
  • Higher significance · 1
  • Moderate · 5
  • Unrated · 2
See the full Budesonide 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 Budesonide — the kind of thing our pharmacy team would talk through with you at the counter.

My child has asthma. Can I use this nebulizer treatment when they're having an attack?
No — and this is really important to understand. Budesonide inhalation suspension is a daily controller medication, not a rescue treatment. It works by slowly calming inflammation in the airways over days to weeks. When your child is in the middle of an attack with sudden, severe wheezing, you need a fast-acting bronchodilator (rescue inhaler) instead. Make sure you always have one on hand, and talk to your child's doctor if you don't.
How long before we see it working?
You may start to notice some improvement in your child's asthma symptoms within 2 to 8 days of starting treatment. But full benefit — where the airways are as calm and well-controlled as possible — typically takes up to 4 to 6 weeks of regular daily use. Consistency is key: it needs to be used every day, even when your child feels fine.
Do I really need to rinse my child's mouth after every treatment?
Yes, please do — it makes a real difference. Inhaled steroids like budesonide can leave a small amount of residue in the mouth and throat, which can lead to a yeast infection called thrush (white patches or soreness in the mouth). Rinsing with water right after each treatment washes that residue away and significantly lowers that risk. Make it part of the nebulizer routine every single time.
Can this steroid affect my child's growth?
Long-term use of inhaled corticosteroids can slow growth rate in some children. That's why your child's doctor will monitor their height regularly while they're on this medication. The goal is always to use the lowest dose that keeps the asthma well-controlled, and doses are adjusted down once things are stable. The risk of poorly controlled asthma generally outweighs the growth concern, but it's absolutely worth discussing with your doctor at each visit.
My child is on another medication. Are there any drugs I need to watch out for?
Yes — certain medications can increase the amount of budesonide that gets into your child's bloodstream, which could cause more steroid side effects than expected. These include some antifungals like ketoconazole and itraconazole, some antibiotics like clarithromycin, and several HIV medications. Before starting any new prescription or even some over-the-counter products, let the prescriber or pharmacist know your child is on budesonide.
What type of nebulizer do I need to use — does it matter?
It matters a lot. Budesonide inhalation suspension must only be used with a jet nebulizer connected to an air compressor — never with an ultrasonic nebulizer. Ultrasonic devices don't deliver this medication properly. Make sure your equipment matches what's prescribed, and always use either a mouthpiece or an appropriate face mask as directed. If you're not sure what you have, bring it to the pharmacy and we can take a look.
Is Budesonide available over the counter?
Both — Budesonide is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Budesonide first available?
Budesonide has been available in the United States since at least 1993, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Budesonide?
Budesonide is supplied by 83 manufacturers listed in the FDA NDC Directory, including A-S Medication Solutions, AstraZeneca Pharmaceuticals LP, Sun Pharmaceutical Industries, Inc..

💬 Answers drafted from Budesonide’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

💊 How Budesonide comes

Budesonide is available in 7 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 Budesonide Inhalation Budesonide Inhalation Suspension Pulmicort Respules
Available strengths 3 strengths
52 FDA-listed product records

Nasal spray

In the nose
Brands RHINOCORT Allergy
Available strengths 1 strength
25 FDA-listed product records

Capsule

By mouth
Brands Ortikos
Available strengths 3 strengths
21 FDA-listed product records

Delayed-release capsule

By mouth
Brands Tarpeyo
Available strengths 2 strengths
16 FDA-listed product records

Extended-release tablet

By mouth
Brands Uceris
Available strengths 1 strength
13 FDA-listed product records

Oral suspension

By mouth
Brands Eohilia
Available strengths 1 strength
1 FDA-listed product record

📊 Budesonide across the U.S. market

How Budesonide 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.

7
Dose forms
83
Manufacturers
13
Brand names
217
FDA-listed product records
1993
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 (41) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions7%
AstraZeneca Pharmaceuticals LP6%
Sun Pharmaceutical Industries, Inc.4%
Amneal Pharmaceuticals of New York LLC4%
Preferred Pharmaceuticals Inc.4%
American Health Packaging4%
Other makers70%

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

📈 How widely Budesonide is used

A general measure of how commonly Budesonide 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 Budesonide 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.

967,284
Medicaid prescriptions filled (Q1–Q4 2025)
$154.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Budesonide prescribed? Of the 1,596 medications we measure, Budesonide ranks #182 by Medicaid prescriptions — more than 89% of them.

Where Budesonide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Budesonide 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 0.25 mg/mL inhalation suspension is the most-dispensed Budesonide product — about 54% of these Medicaid prescriptions.

budesonide 0.25 MG/ML Inhalation Suspension Most dispensed

524,097 Medicaid prescriptions (Q1–Q4 2025) 54% of Budesonide prescriptions shown $43.5M gross reimbursement (before rebates) ≈ $83 per prescription (gross)

Summed across the 14 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 351109

budesonide 0.125 MG/ML Inhalation Suspension

226,081 Medicaid prescriptions (Q1–Q4 2025) 23% of Budesonide prescriptions shown $18.7M gross reimbursement (before rebates) ≈ $83 per prescription (gross)

Summed across the 9 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349094

budesonide 0.5 MG/ML Inhalation Suspension

52,509 Medicaid prescriptions (Q1–Q4 2025) 5% of Budesonide prescriptions shown $18.3M gross reimbursement (before rebates) ≈ $349 per prescription (gross)

Summed across the 6 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 252559

60 ACTUAT budesonide 0.09 MG/ACTUAT Dry Powder Inhaler

51,285 Medicaid prescriptions (Q1–Q4 2025) 5% of Budesonide prescriptions shown $10.8M gross reimbursement (before rebates) ≈ $211 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 966527

budesonide 3 MG Delayed Release Oral Capsule

44,768 Medicaid prescriptions (Q1–Q4 2025) 5% of Budesonide prescriptions shown $3.2M gross reimbursement (before rebates) ≈ $71 per prescription (gross)

Summed across the 4 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1244214

120 ACTUAT budesonide 0.18 MG/ACTUAT Dry Powder Inhaler

39,155 Medicaid prescriptions (Q1–Q4 2025) 4% of Budesonide prescriptions shown $10.7M gross reimbursement (before rebates) ≈ $273 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 966522

budesonide 0.032 MG/ACTUAT Metered Dose Nasal Spray

20,113 Medicaid prescriptions (Q1–Q4 2025) 2% of Budesonide prescriptions shown $388,554 gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 3 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1797929

24 HR budesonide 9 MG Extended Release Oral Tablet

3,246 Medicaid prescriptions (Q1–Q4 2025) <1% of Budesonide prescriptions shown $2.5M gross reimbursement (before rebates) ≈ $778 per prescription (gross)

Summed across the 4 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1366550

budesonide 0.2 MG/ML Oral Suspension

3,205 Medicaid prescriptions (Q1–Q4 2025) <1% of Budesonide prescriptions shown $5.9M gross reimbursement (before rebates) ≈ $1,842 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 2675280

budesonide 4 MG Delayed Release Oral Capsule

2,288 Medicaid prescriptions (Q1–Q4 2025) <1% of Budesonide prescriptions shown $39.8M gross reimbursement (before rebates) ≈ $17,381 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2587883

14 ACTUAT budesonide 2 MG/ACTUAT Rectal Foam

537 Medicaid prescriptions (Q1–Q4 2025) <1% of Budesonide prescriptions shown $326,563 gross reimbursement (before rebates) ≈ $608 per prescription (gross)

Summed across the 3 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1596779

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 Budesonide, 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 48 of 170 listed Budesonide NDCs with Medicaid activity.

🔍 Compare Budesonide products

A representative set of FDA-listed product records for Budesonide — 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 217 products — FDA National Drug Code Directory. See every product, package size and price: browse all 217 Budesonide 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) Budesonide RxCUI 19831 11 dose forms · 16 strengths
  1. Dose form (SCDF) Delayed Release Oral Capsule RxCUI 1489770 In current FDA listings
    Clinical drug / strength (SCD) 3 MG RxCUI 1244214 4 MG RxCUI 2587883
  2. Dose form (SCDF) Enema RxCUI 381066 No current FDA listing
  3. Dose form (SCDF) Extended Release Oral Capsule RxCUI 2269304 No current FDA listing
    Clinical drug / strength (SCD) 24 HR budesonide 6 MG RxCUI 2269305 24 HR budesonide 9 MG RxCUI 2269307
  4. Dose form (SCDF) Extended Release Oral Tablet RxCUI 1366549 In current FDA listings
    Clinical drug / strength (SCD) 24 HR budesonide 9 MG RxCUI 1366550
  5. Dose form (SCDF) Inhalation Powder RxCUI 2108302 No current FDA listing
    Clinical drug / strength (SCD) 0.2 MG RxCUI 247047
  6. Dose form (SCDF) Inhalation Suspension RxCUI 2108295 In current FDA listings
    Clinical drug / strength (SCD) 0.125 MG/ML RxCUI 349094 0.25 MG/ML RxCUI 351109 0.5 MG/ML RxCUI 252559
  7. Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797928 In current FDA listings
    Clinical drug / strength (SCD) 0.032 MG/ACTUAT RxCUI 1797929
  8. Dose form (SCDF) Nasal Spray RxCUI 371152 In current FDA listings
    Clinical drug / strength (SCD) 0.05 MG/ACTUAT RxCUI 247042 0.1 MG/ACTUAT RxCUI 247691
  9. Dose form (SCDF) Oral Suspension RxCUI 2675279 In current FDA listings
    Clinical drug / strength (SCD) 0.2 MG/ML RxCUI 2675280

Look up RxCUI 19831 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

Entocort EC Tarpeyo Uceris Rhinocort Ortikos Eohilia Pulmicort Budesonide Inhalation Pulmicort Flexhaler Budesonide Inhalation Suspension Pulmicort Respules RHINOCORT Allergy

🏭 Manufacturers & labelers

A-S Medication Solutions 11 AstraZeneca Pharmaceuticals LP 10 Sun Pharmaceutical Industries, Inc. 7 Amneal Pharmaceuticals of New York LLC 7 Preferred Pharmaceuticals Inc. 7 American Health Packaging 6 Sandoz Inc 6 Cipla USA Inc. 6 Golden State Medical Supply, Inc. 5 Apotex Corp. 5 Teva Pharmaceuticals USA, Inc. 5 Rising Pharma Holdings, Inc. 4 H2-Pharma LLC 4 Rubicon Holdings Inc. 4 Oceanside Pharmaceuticals 4 Bryant Ranch Prepack 4 Rugby Laboratories 4 Nephron Pharmaceuticals Corporation 4 Industriale Chimica s.r.l. 3 Northstar Rx LLC. 3 Mylan Pharmaceuticals Inc. 3 Walgreens 3 Lupin Pharmaceuticals, Inc. 3 Major Pharmaceuticals 3

…and 16 more on the FDA NDC directory.

RxNorm drug class

Budesonide belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Corticosteroids, potent (group III), Corticosteroids
How it works Corticosteroid Hormone Receptor 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 Jun 10, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Budesonide.
📈
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 Budesonide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
33
NDC products indexed
217
Distinct labelers/manufacturers represented
83
Linked representative label
Cipla USA Inc.
Linked label effective
Jun 10, 2026
Composite sections available
23
Linked SPL Set ID
c52c5382-1400-44b9-95be-a30e1cf706da
Linked SPL Document ID
29644146-4bcf-49d0-80b3-e31f4b3a6f54
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 33 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. Cipla USA 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.