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Budesonide .5 mg/2mL Suspension — NDC 62135-0823-84 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Budesonide .5 mg/2mL Suspension — NDC 62135-823-84 (Billing 62135-0823-84)

by Chartwell RX, LLC · 6 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE

This is a package of Budesonide .5 mg/2mL Suspension from Chartwell RX, LLC, marketed since Oct 2013 and currently FDA-listed; retail pharmacies pay about $0.6761 per mL (NADAC). It is this product's only package size.

NDC 62135-0823-84
🏷️ FDA NDC (as labeled) 62135-823-84 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 Budesonide (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 29, 2026 — Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0607-2026
Class II · Jun 30, 2025 — Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. (Cipla USA, Inc.) · FDA recall D-0541-2025
Class II · Jan 8, 2024 — Failed Dissolution Specifications (Teva Pharmaceuticals USA, Inc) · FDA recall D-0275-2024
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) 62135-823-84
Product NDC 62135-823
11-digit billing NDC 62135082384
NCPDP billing unit ML — per mL (volume)
RxCUI 349094, 351109
UNII Q3OKS62Q6X
Application # ANDA078202
SPL Set ID 374013c9-18c9-4419-b9fb-9bc5c765688e
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-10-01
Route RESPIRATORY (INHALATION)
Dosage form SUSPENSION
Substance BUDESONIDE
TE code (Orange Book) AN · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 44400015001840
GCN Seq No 046526
GCN 17958
HICL code 006545
Ingredient (HICL) Budesonide
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B6
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code B6M
Therapeutic class — specific (HIC3) Glucocorticoids, Orally Inhaled
AHFS code 68:04.00.00
AHFS class Adrenals
FDB label name BUDESONIDE 0.5 MG/2 ML SUSP
FDB brand name Budesonide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 046526
  • GCN: 17958
  • GPI-14 (Medi-Span): 44400015001840
  • HICL (First Databank): 006545
  • AHFS class code: 68:04.00.00
  • RxCUI (RxNorm): 349094
Why two NDCs? The FDA registers this code as 62135-823-84 — 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 → 62135-0823-84. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Corticosteroids, potent (group III), Corticosteroids
How it works Corticosteroid Hormone Receptor Agonists
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

Label name BUDESONIDE 0.5 MG/2 ML SUSP Ingredient Budesonide
📖 What it is MedlinePlus · NLM

Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Budesonide powder for oral inhalation (Pulmicort Flexhaler) is used in adults and children 6 years of age and older. Budesonide suspension (liquid) for oral inhalation (Pulmicort Respules) is used in children 12 months to 8 years of age. Budesonide belongs to a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It calms inflammation. Depending on the product, that means asthma, Crohn’s disease, ulcerative colitis, eosinophilic esophagitis or IgA nephropathy. Your product was chosen for yo...
  • No. It is for long-term control, not quick relief. If your asthma gets worse and your usual rescue medicine doesn’t help, contact your doctor right away.
  • Can I use my budesonide inhaler or nebulizer for a sudden asthma attack?
  • Rinse your mouth with water after each use and don’t swallow it. This lowers the chance of a yeast infection (thrush). Tell us if you notice white patches or soreness.
📖 Read our full Budesonide guide →
8
Nutrient depletion considerations

Budesonide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Budesonide 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 mLPer package
Retail pharmacies payNADAC · weekly $0.676 $40.57 / 60 ml
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 · Q2 2026 $1.20 $72.14 / 60 ml
Medicare Part B allowsASP · J7626 $1.092 / J7626 unit —
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.796 $0.676
▼ Down 15% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)62135-823-84
11-digit billing NDC62135-0823-84
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7626
DescriptorBUDESONIDE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, UP TO 0.5 MG
Billing units / pkg0.5 units
How the units are derivedThis package is 2 ML; the HCPCS unit is 0.5 MG, so one package = 0.5 billing units.
Medicare Part B spend (2026 (Q1))$5,491,457 · 84,831 claims · $64.73 per claim (all NDCs under J7626)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
62135-0823-84 You're viewing this Main listing 6 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE 2024-01-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Budesonide .5 mg/2mL 00093-6816-55 Teva 30 pouches $0.676 AN Availability likely —
Budesonide Inhalation .5 mg/2mL 00115-1689-74 Amneal 6 pouches $0.676 AN Availability likely —
Budesonide .5 mg/2mL 00487-9701-01 Nephron 6 pouches $0.676 AN Availability likely —
Budesonide .5 mg/2mL 47335-0632-49 Sun 6 pouches $0.676 AN Availability likely —
Budesonide .5 mg/2mL 59651-0585-30 Aurobindo 6 pouches $0.676 AN Availability likely —
Budesonide Inhalation .5 mg/2mL 60687-0524-83 American 30 pouches $0.676 AN Availability likely —
Budesonide .5 mg/2mLthis 62135-0823-84 Chartwell 6 pouches $0.676 AN Availability likely —
Budesonide .5 mg/2mL 64980-0639-03 Rising 30 pouches $0.676 AN Availability likely —
budesonide inhalation .5 mg/2mL 68180-0984-30 Lupin 6 pouches $0.676 AN Availability likely —
Budesonide Inhalation Suspension .5 mg/2mL 69097-0319-53 Cipla 30 pouches $0.676 AN Availability likely —
Budesonide Inhalation Suspension .5 mg/2mL 76282-0641-38 Exelan 6 pouches $0.676 AN Availability likely —
Budesonide .5 mg/2mL 00781-7516-87 Sandoz 6 pouches $0.730 — Discontinued +8%
Pulmicort Respules .5 mg/2mL 00186-1989-04 AstraZeneca 6 pouches $4.911 AN Availability likely +626%
Budesonide .5 mg/2mL 50090-6586-00 A-S 6 pouches — AN FDA listed —
budesonide inhalation .5 mg/2mL 50090-7126-00 A-S 6 pouches — AN FDA listed —
Budesonide .5 mg/2mL 55154-4849-05 Cardinal 5 vials — AN FDA listed —
Budesonide Inhalation Suspension .5 mg/2mL 68788-7314-03 Preferred 6 pouches — AN FDA listed —
budesonide inhalation .5 mg/2mL 68788-8503-03 Preferred 6 pouches — AN 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

🏛️
2013
On the market since
Oct 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

LabelerChartwell RX, LLC
Application holderNEPHRON PHARMACEUTICALS CORPORATION
FDA applicationANDA078202 (ANDA)
Labeler code62135
First marketedOct 2013
Product typeHuman Prescription Drug
Portfolio521 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 91 words ▾

1 INDICATIONS AND USAGE Budesonide inhalation suspension is an inhaled corticosteroid indicated for: Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 )

1.1Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended starting dose and highest recommended dose of budesonide inhalation suspension, based on prior asthma therapy, are listed in the following table. Previous Therapy Recommended Starting Dose Highest Recommended Dose Bronchodilators Alone 0.5 mg total daily dose administered twice daily in divided doses 0.5 mg total daily dose Inhaled Corticosteroids 0.5 mg total daily dose administered twice daily in divided doses 1 mg total daily dose Oral Corticosteroids 1 mg total daily dose administered as 0.5 mg twice daily 1 mg total daily dose Recommended dosing based on previous therapy ( 2 ).

Start with the lowest recommended dose: Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily Oral corticosteroids: 0.5 mg twice daily In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered. If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a divided dose. Once asthma stability is achieved, titrate the dose downwards.

For inhalation use via compressed air driven jet nebulizers only (not for use with ultrasonic devices). Not for injection. ( 2.2 )

2.1Dosing Recommendations Dosing recommendations based on previous therapy are as follows: Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily Inhaled corticosteroids 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily Oral corticosteroids: 0.5 mg twice daily In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered. If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a divided dose.

In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved.

2.2Directions for Use Budesonide inhalation suspension should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of budesonide inhalation suspension and, therefore, are NOT recommended. The effects of mixing budesonide inhalation suspension with other nebulizable medications have not been adequately assessed.

Budesonide inhalation suspension should be administered separately in the nebulizer [see Patient Counseling Information,(17.1) ]. A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver budesonide inhalation suspension to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of budesonide inhalation suspension delivered by other nebulizers and compressors have not been established.

💊 Dosage Forms and Strengths 89 words ▾

3 DOSAGE FORMS AND STRENGTHS Budesonide inhalation suspension is available in two strengths, each containing 2 mL: 0.25 mg/2 mL and 0.5 mg/2 mL. Budesonide inhalation suspension is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose ampules or in individually wrapped single-dose ampules, together with patient instructions for use. There are 30 budesonide inhalation suspension ampules in a carton.

Each single-dose budesonide inhalation suspension ampule contains 2 mL of sterile liquid suspension. Inhalation suspension: 0.25 mg/2 mL and 0.5 mg/2 mL. ( 3 )

⛔ Contraindications 87 words ▾

4 CONTRAINDICATIONS The use of budesonide inhalation suspension is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see Warnings and Precautions (5.3) , Description (11) and Adverse Reactions (6.2) ]. Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

( 4.1 ) Hypersensitivity to any of the ingredients in budesonide inhalation suspension ( 4.2 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth following inhalation.

( 5.1 ) Deterioration of disease and acute asthma episodes: Do not use for the relief of acute bronchospasm. ( 5.2 ) Hypersensitivity reactions: anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of budesonide inhalation suspension. Discontinue budesonide inhalation suspension if such reactions occur ( 5.3 ) Immunosuppression: Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex).

Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. ( 5.4 ) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids.

Taper patients slowly from systemic corticosteroids if transferring to budesonide inhalation suspension ( 5.5 ) Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, reduce budesonide inhalation suspension slowly. ( 5.6 ) Reduction in bone mineral density with long term administration.

Monitor patients with major risk factors for decreased bone mineral content. ( 5.7 ) Effects on growth: Monitor growth of pediatric patients. ( 5.8 ) Glaucoma and cataracts: Close monitoring is warranted.

( 5.9 ) Paradoxical bronchospasm: Discontinue budesonide inhalation suspension and institute alternative therapy if paradoxical bronchospasm occurs. ( 5.10 ) Eosinophilic conditions and Churg-Strauss syndrome: Be alert to eosinophilic conditions. ( 5.11 )

5.1Local Effects In clinical trials with budesonide inhalation suspension localized infections with Candida albicans occurred in the mouth and pharynx in some patients. The incidences of localized infections of Candida albicans were similar between the placebo and budesonide inhalation suspension treatment groups. If these infections develop, they may require treatment with appropriate local or systemic antifungal therapy and/or discontinuance of treatment with budesonide inhalation suspension.

Patients should rinse the mouth after inhalation of budesonide inhalation suspension.

5.2Deterioration of Disease and Acute Asthma Episodes Budesonide inhalation suspension is not a bronchodilator and is not indicated for the rapid relief of acute bronchospasm or other acute episodes of asthma. Patients should be instructed to contact their physician immediately if episodes of asthma not responsive to their usual doses of bronchodilators occur during the course of treatment with budesonide inhalation suspension. During such episodes, patients may require therapy with oral corticosteroids.

5.3Hypersensitivity Reactions Including Anaphylaxis Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of budesonide inhalation suspension. Discontinue budesonide inhalation suspension if such reactions occur [see Contraindications (4) ].

5.4Immunosuppression Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases, or been properly immunized, particular care should be taken to avoid exposure.

How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed t… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Systemic and inhaled corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions (5.1) ] Hypersensitivity reactions including anaphylaxis [see Warnings and Precautions (5.3) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypercorticism and adrenal suppression [see Warnings and Precautions (5.6) ] Reduction in bone mineral density [see Warnings and Precautions (5.7) ] Growth effects in pediatric patients [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4) ] Glaucoma, increased intraocular pressure and cataracts [see Warnings and Precautions (5.9) ] Eosinophilic conditions and Churg-Strauss syndrome [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence >3%) are respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The incidence of common adverse reactions is based on three double-blind, placebo-controlled, randomized U.S. clinical trials in which 945 patients, 12 months to 8 years of age, (98 patients ≥12 months and <2 years of age; 225 patients ≥2 and <4 years of age; and 622 patients ≥4 and ≤8 years of age) were treated with budesonide inhalation suspension (0.25 to 1 mg total daily dose for 12 weeks) or vehicle placebo.

The incidence and nature of adverse events reported for budesonide inhalation suspension was comparable to that reported for placebo. The following table shows the incidence of adverse events in U.S. controlled clinical trials, regardless of relationship to treatment, in patients previously receiving bronchodilators and / or inhaled corticosteroids. This population included a total of 605 male and 340 female patients and 78.4% were Caucasian, 13.8% African American, 5.5% Hispanic and 2.3% Other.

Table 1 – Adverse Reactions occurring at an incidence of ≥3% in at least one active treatment group where the incidence was higher with budesonide inhalation suspension than placebo Adverse Events Vehicle Placebo (n=227) % 0.25 mg (n=178) % Budesonide Inhalation Suspension Total Daily Dose 0.5 mg (n=223) % 1 mg (n=317) % Respiratory System Disorder Respiratory Infection 36 34 73 38 Rhinitis 9 7 11 12 Coughing 5 5 9 8 Resistance Mechanism Disorders Otitis Media 11 12 11 9 Viral Infection 3 4 5 3 Moniliasis 2 4 3 4 Gastrointestinal System Disorders Gastroenteritis 4 5 5 5 Vomiting 3 2 4 4 Diarrhea 2 4 4 2 Abdominal Pain 2 3 2 3 Hearing and Vestibular Disorders Ear Infection 4 2 4 5 Platelet, Bleeding and Clotting Disorders Epistaxis 1 2 4 3 Vision Disorders Conjunctivitis 2 < 1 4 2 Skin and Appendages Disorders Rash 3 < 1 4 2 The information below includes all adverse reactions by system organ class with an incidence of 1 to < 3%, in at least one budesonide inhalation suspension treatment group where the incidence was higher with budesonide inhalation suspension than with placebo, regardless of relationship to treatment.

Blood and lymphatic system disorders: cervical lymphadenopathy Ear and labyrinth disorders: earache General disorders and administration site conditions: fatigue, flu-like disorder Immune system disorders: allergic reaction Infections and infestations: eye infection, herpes simplex, external ear infection, infection Injury, poisoning and procedural complication: fracture Metabolism and nutrition disorders: anorexia Musculoskeletal and connective tissue disorders: myalgia Nervous system disorders: hyperkinesia Psychiatric diso… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 124 words ▾

7 DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects. ( 5.12 , 7.1 )

7.1Inhibitors of Cytochrome P4503A4 The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide.

Caution should be exercised when considering the coadministration of budesonide inhalation suspension with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.12) and Clinical Pharmacology (12.3) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate well-controlled studies of budesonide inhalation suspension in pregnant women. However, there are published studies on the use of budesonide, the active ingredient in budesonide inhalation suspension, in pregnant women. In animal reproduction studies, budesonide, administered by the subcutaneous route, caused structural abnormalities, was embryocidal, and reduced fetal weights in rats and rabbits at less than the maximum recommended human daily inhalation dose (MRHDID), but these effects were not seen in rats that received inhaled doses approximately 2 times the MRHDID (see Data).

Studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. Experience with oral corticosteroids suggests that rodents are more prone to structural abnormalities from corticosteroid exposure than humans. The estimated background risk of major birth defects and miscarriage of the indicated populations is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal risk In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control.

Labor or Delivery There are no well-controlled human studies that have investigated the effects of budesonide inhalation suspension during labor and delivery. Data Human Data Studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. The results from a large population-based prospective cohort epidemiological study reviewing data from three Swedish registries covering approximately 99% of the pregnancies from 1995-1997 (i.e., Swedish Medical Birth Registry; Registry of Congenital Malformations; Child Cardiology Registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy.

Congenital malformations were studied in 2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10-12 weeks after the last menstrual period), the period when most major organ malformations occur. The rate of recorded congenital malformations was similar compared to the general population rate (3.8% vs. 3.5%, respectively).

In addition, after exposure to inhaled budesonide, the number of infants born with orofacial clefts was similar to the expected number in the normal population (4 children vs. 3.3, respectively). These same data were utilized in a second study bringing the total to 2534 infants whose mothers were exposed to inhaled budesonide.

In this study, the rate of congenital malformations among infants whose mothers were exposed to inhaled budesonide during early pregnancy was not different from the rate for all newborn babies during the same period (3.6%). Animal Data In a fertility and reproduction study, male rats were subcutaneously dosed for 9 weeks and females for 2 weeks prior to pairing and throughout the mating period. Females were dosed up until weaning of their offspring.

Budesonide caused a decrease in prenatal viability and viability in the pups at birth and during lactation, along with a decrease in maternal body-weight gain, at doses 0.2 times the MRHDID (on a mcg/m 2 basis at maternal subcutaneous doses of 20 mcg/kg/day and above). No such effects were noted at a dose 0.05 times the MRHDID (on a mcg/m 2 basis at a maternal subcutaneous dose of 5 mcg/kg/day). In an embryo-fetal development study in pr… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 44 words ▾

10 OVERDOSAGE The potential for acute toxic effects following overdose of budesonide inhalation suspension is low. If inhaled corticosteroids are used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism or growth suppression may occur [see Warnings and Precautions (5.6) ].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. In standard in vitro and animal models, budesonide has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol (rat croton oil ear edema assay). As a measure of systemic activity, budesonide is 40 times more potent than cortisol when administered subcutaneously and 25 times more potent when administered orally in the rat thymus involution assay.

The clinical significance of these findings is unknown. The activity of budesonide inhalation suspension is due to the parent drug, budesonide. In glucocorticoid receptor affinity studies, the 22R form was two times as active as the 22S epimer.

In vitro studies indicated that the two forms of budesonide do not interconvert. The precise mechanism of corticosteroid actions on inflammation in asthma is not well known. Inflammation is an important component in the pathogenesis of asthma.

Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic- and non-allergic-mediated inflammation. The anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma. Studies in asthmatic patients have shown a favorable ratio between topical anti-inflammatory activities and systemic corticosteroid effects over a wide dose range of inhaled budesonide in a variety of formulations and delivery systems including an inhalation-driven, multi-dose dry powder inhaler and the inhalation suspension for nebulization.

This is explained by a combination of a relatively high local anti-inflammatory effect, extensive first pass hepatic degradation of orally absorbed drug (85 to 95%) and the low potency of metabolites (see below).

12.2Pharmacodynamics The therapeutic effects of conventional doses of orally inhaled budesonide are largely explained by its direct local action on the respiratory tract. To confirm that systemic absorption is not a significant factor in the clinical efficacy of inhaled budesonide, a clinical study in adult patients with asthma was performed comparing 400 mcg budesonide administered via a pressurized metered dose inhaler with a tube spacer to 1400 mcg of oral budesonide and placebo. The study demonstrated the efficacy of inhaled budesonide but not orally administered budesonide, even though systemic budesonide exposure was comparable for both treatments, indicating that the inhaled treatment is working locally in the lung.

Thus, the therapeutic effect of conventional doses of orally inhaled budesonide are largely explained by its direct action on the respiratory tract. Improvement in the control of asthma symptoms following inhalation of budesonide inhalation suspension can occur within 2 to 8 days of beginning treatment, although maximum benefit may not be achieved for 4 to 6 weeks. Budesonide administered via a dry powder inhaler has been shown in various challenge models (including histamine, methacholine, sodium metabisulfite, and adenosine monophosphate) to decrease bronchial hyperresponsiveness in asthmatic patients.

The clinical relevance of these models is not certain. Pre-treatment with budesonide administered as 1600 mcg daily (800 mcg twice daily) via a dry powder inhaler for 2 weeks reduced the acute (early-phase reaction) and delayed (late-phase reaction) decrease in FEV 1 following inhaled allergen challenge. HPA Axis Effects The effects of budesonide inhalation suspension on the hypothalamic-pituitary-adrenal (HPA) axis were studied in three, 12-week, double-blind, placebo-controlled studies in 293 pediatric patients, 6 months to 8 years of age, with persistent asthma.

For mos… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 189 words ▾

16 HOW SUPPLIED / STORAGE AND HANDLING Budesonide inhalation suspension is supplied in sealed aluminum foil envelopes containing one plastic strip of five single-dose ampules or in individually wrapped single-dose ampules, together with patient instructions for use. There are 30 ampules in a carton. Each single-dose ampule contains 2 mL of sterile liquid suspension.

Budesonide inhalation suspension is available in two strengths, each containing 2 mL: NDC 62135-822-84 0.25 mg/2 mL 6 foil pouches, each containing 5 ampules, total 30 ampules per carton NDC 62135-823-84 0.5 mg/2 mL 6 foil pouches, each containing 5 ampules, total 30 ampules per carton Budesonide inhalation suspension should be stored upright at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP], and protected from light. When an envelope has been opened, the shelf life of the unused ampules is 2 weeks when protected.

After opening the aluminum foil envelope, the unused ampules should be returned to the aluminum foil envelope to protect them from light. Any opened ampule must be used promptly. Gently shake the ampule using a circular motion before use.

Keep out of reach of children. Do not freeze.

📋 Description ~1 min read ▾

11 DESCRIPTION Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5.

Its structural formula is: Budesonide is a white or almost white, crystalline powder that is practically insoluble in water, sparingly soluble in ethanol, and freely soluble in methylene chloride. Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients citric acid, edetate disodium dihydrate, polysorbate 80, sodium chloride, sodium citrate, and water for injection. Two dose strengths are available in single-dose ampules: 0.25 mg and 0.5 mg per 2 mL ampule.

For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of

5.5L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration(2) ]. image description

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION

17.1Administration with a Jet Nebulizer Patients should be advised that budesonide inhalation suspension should be administered with a jet nebulizer connected to a compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of budesonide inhalation suspension and, therefore, are not recommended. The effects of mixing budesonide inhalation suspension with other nebulizable medications have not been adequately assessed.

Budesonide inhalation suspension should be administered separately in the nebulizer [see Dosage and Administration (2) ] .

17.2Oral Candidiasis Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e. oral) antifungal therapy while still continuing therapy with budesonide inhalation suspension, but at times therapy with budesonide inhalation suspension may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised [see Warnings and Precautions (5.1) ] .

17.3Not for Acute Symptoms Budesonide inhalation suspension is not meant to relieve acute asthma symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta 2-agonist such as albuterol. (The healthcare professional should provide that patient with such medication and instruct the patient in how it should be used.) Patients should be instructed to notify their healthcare professional immediately if they experience any of the following: Decreasing effectiveness of inhaled, short-acting beta 2-agonists Need for more inhalations than usual of inhaled, short-acting beta 2-agonists Significant decrease in lung function as outlined by the physician Patients should not stop therapy with budesonide inhalation suspension without physician/provider guidance since symptoms may recur after discontinuation [see Warnings and Precautions (5.2) ] .

17.4Hypersensitivity including Anaphylaxis Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of budesonide inhalation suspension. Discontinue budesonide inhalation suspension if such reactions occur [see Contraindications (4) ; Warning and Precautions (5.3) ] .

17.5Immunosuppression Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. If exposure to such a person occurs, and the child has not had chicken pox or been properly vaccinated, a physician should be consulted without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex [see Warnings and Precautions (5.4) ] .

17.6Hypercorticism and Adrenal Suppression Patients should be advised that budesonide inhalation suspension may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, patients should be instructed that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to budesonide inhalation suspension [see Warnings and Precautions (5.6) ] .

17.7Reduction in Bone Mineral Density Patients who are at an increased risk for decreased BMD should be advised that the use of corticosteroids may pose an additional risk [see Warnings and Precautions (5.7) ]

17.8Reduced Growth Velocity Patients should be informed that orally inhaled corticosteroids, including budesonide, may cause a reduction in growth velocity when administered to pediatric patients. Healthcare professionals sho… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Three double-blind, placebo-controlled, parallel group, randomized U.S. clinical trials of 12-weeks duration each were conducted in 1018 pediatric patients, 6 months to 8 years of age, 657 males and 361 females (798 Caucasians, 140 Blacks, 56 Hispanics, 3 Asians, 21 Others) with persistent asthma of varying disease duration (2 to 107 months) and severity. Doses of 0.25 mg, 0.5 mg and 1 mg administered either once or twice daily were compared to placebo to provide information about appropriate dosing to cover a range of asthma severity.

A Pari-LC-Jet Plus Nebulizer (with a face mask or mouthpiece) connected to a Pari Master compressor was used to deliver budesonide inhalation suspension to patients in the 3 U.S. controlled clinical trials. The co-primary endpoints were nighttime and daytime asthma symptom scores (0 to 3 scale). Improvements were addressed in terms of the primary efficacy variables of changes from baseline to the double-blind treatment period in nighttime and daytime asthma symptom scores (scale 0 to 3) as recorded in the patient diaries.

Baseline was defined as the mean of the last seven days prior to randomization). The double-blind treatment period was defined as the mean over 12 week treatment period. Each of the five doses discussed below were studied in one or two, but not all three of the U.S. studies.

Results of the 3 controlled clinical trials for recommended dosages of budesonide inhalation suspension (0.25 mg to 0.5 mg once or twice daily, or 1 mg once daily, up to a total daily dose of 1 mg) in 946 patients, 12 months to 8 years of age, are presented below. Statistically significant decreases in nighttime and daytime symptom scores of asthma were observed at budesonide inhalation suspension doses of 0.25 mg once daily (one study), 0.25 mg twice daily, and 0.5 mg twice daily compared to placebo. Use of budesonide inhalation suspension resulted in statistically significant decreases in either nighttime or daytime symptom scores, but not both, at doses of 1 mg once daily, and 0.5 mg once daily (one study).

Symptom reduction in response to budesonide inhalation suspension occurred across gender and age. Statistically significant reductions in the need for bronchodilator therapy were also observed at all the doses of budesonide inhalation suspension studied. Improvements in lung function were associated with budesonide inhalation suspension treatment in the subgroup of patients capable of performing lung function testing.

Statistically significant increases were seen in FEV 1 [budesonide inhalation suspension 0.5 mg once daily and 1 mg once daily (one study); 0.5 mg twice daily] and morning PEF [budesonide inhalation suspension 1 mg once daily (one study); 0.25 mg twice daily; 0.5 mg twice daily] compared to placebo. A numerical reduction in nighttime and daytime symptom scores (0 to 3 scale) of asthma was observed within 2 to 8 days, although maximum benefit was not achieved for 4 to 6 weeks after starting treatment. The reduction in nighttime and daytime asthma symptom scores was maintained throughout the 12 weeks of the double-blind trials.

Patients Not Receiving Inhaled Corticosteroid Therapy The efficacy of budesonide inhalation suspension at doses of 0.25 mg, 0.5 mg, and 1 mg once daily was evaluated in 344 pediatric patients, 12 months to 8 years of age, with mild to moderate persistent asthma (mean baseline nighttime asthma symptom scores of the treatment groups ranged from 1.07 to 1.34) who were not well controlled by bronchodilators alone. The changes from baseline to Weeks 0-12 in nighttime asthma symptom scores are shown in Figure 1. Nighttime asthma symptom scores showed statistically significant decreases in the patients treated with budesonide inhalation suspension compared to placebo.

Similar decreases were also observed for daytime asthma symptom scores. Changes from baseline to the double-blind phase for the budesonide treatment groups compared to placebo were made us… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a two-year study in Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of gliomas in male rats at an oral dose of 50 mcg/kg (approximately 0.5 and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/m 2 basis). No tumorigenicity was seen in male rats at oral doses up to 25 mcg/kg (approximately 0.2 and 0.06 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/m 2 basis) and in female rats at oral doses up to 50 mcg/kg (approximately 0.4 and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/m 2 basis).

In two additional two-year studies in male Fischer and Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of 50 mcg/kg (approximately 0.4 and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/m 2 basis). However, in the male Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of hepatocellular tumors at an oral dose of 50 mcg/kg (approximately 0.4 and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/m 2 basis).

The concurrent reference corticosteroids (prednisolone and triamcinolone acetonide) in these two studies showed similar findings. In a 91-week study in mice, budesonide caused no treatment-related carcinogenicity at oral doses up to 200 mcg/kg (approximately equivalent to and 0.1 times, respectively, the MRHDID in adults and children 12 months to 8 years of age on a mcg/m 2 basis). Budesonide was not mutagenic or clastogenic in six different test systems: Ames Salmonella /microsome plate test, mouse micronucleus test, mouse lymphoma test, chromosome aberration test in human lymphocytes, sex-linked recessive lethal test in Drosophila melanogaster , and DNA repair analysis in rat hepatocyte culture.

Fertility and reproductive performance were unaffected in rats at subcutaneous doses up to 80 mcg/kg approximately equivalent to the MRHDID in adults on a mcg/m 2 basis. However, it caused a decrease in prenatal viability and viability in the pups at birth and during lactation, along with a decrease in maternal body-weight gain, at subcutaneous doses of 20 mcg/kg and above approximately 0.2 times than the MRHDID in adults on a mcg/m 2 basis. No such effects were noted at 5 mcg/kg (approximately 0.05 times the MRHDID in adults on a mcg/m 2 basis).

📄 Patient Package Insert ~3 min read ▾

Patient Information and Instructions for Use Budesonide (bew DEH so nide) (budesonide) inhalation suspension 2 mL ampules containing 0.25 mg or 0.5 mg For inhalation only. Do not swallow. Only use budesonide inhalation suspension with a jet nebulizer machine that is connected to an air compressor.

Do not use with an ultrasonic nebulizer. Read the Patient Information that comes with budesonide inhalation suspension before your child starts using it and each time you get a refill. There may be new information.

This information does not take the place of talking with your healthcare provider about your child's medical condition or treatment. If you have any questions about budesonide inhalation suspension, ask your healthcare provider or pharmacist. What is budesonide inhalation suspension?

Budesonide inhalation suspension is an inhaled corticosteroid medicine. Budesonide inhalation suspension is a long-term maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. Inhaled corticosteroids help to decrease inflammation in the lungs.

Inflammation in the lungs can lead to asthma symptoms. Budesonide inhalation suspension helps reduce swelling and inflammation in the lungs, and helps keep the airways open to reduce asthma symptoms. Budesonide inhalation suspension does not treat the sudden symptoms (wheezing, cough, shortness of breath, and chest pain or tightness) of an asthma attack.

Always have a short-acting beta 2 -agonist medicine (rescue inhaler) with you to treat sudden symptoms. If your child does not have an inhaled, short-acting bronchodilator, ask your healthcare provider to have one prescribed for your child. It is not known if budesonide inhalation suspension is safe or effective in children younger than 12 months or older than 8 years.

Who should not use budesonide inhalation suspension? Do not use budesonide inhalation suspension: to treat sudden symptoms of asthma if your child is allergic to budesonide or any of the ingredients in budesonide inhalation suspension. See the end of this leaflet for a complete list of ingredients in budesonide inhalation suspension.

What should I tell my healthcare provider before using budesonide inhalation suspension? Before your child uses budesonide inhalation suspension, tell your healthcare provider if your child: has an allergy. See the section "Who should not use budesonide inhalation suspension?" There is a complete list of ingredients in budesonide inhalation suspension at the end of this leaflet. has or recently had chicken pox or measles, or has recently been near anyone with chicken pox or measles. has or had tuberculosis of the respiratory tract. has certain kinds of infections that have not been treated, including: fungal infections bacterial infections viral infections parasitic infections herpes simplex infection of the eye (ocular herpes simplex) Budesonide inhalation suspension may not be right for children who have had any of these types of infections. has decreased bone mineral density (bone strength).

Your child is at risk for decreased bone mineral density if he or she: is inactive for a long period of time has a family history of osteoporosis does not eat well (poor nutrition) takes bone thinning medicines (such as anticonvulsant medicines or corticosteroids) for a long time. has an eye problem such as increased pressure in the eye, glaucoma or cataracts. has liver problems. is planning to have surgery. has any other medical conditions. is pregnant or plans to become pregnant. It is not known if budesonide inhalation suspension will harm your unborn baby. is breast-feeding or plans to breast-feed.

Budesonide inhalation suspension can pass into breast milk. You and your healthcare provider should decide if you will use budesonide inhalation suspension or breast-feed. Tell your healthcare provider about all the medicine your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplem… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 33 words ▾

PRINCIPAL DISPLAY PANEL Budesonide Inhalation Suspension 0.25 mg/2 mL - NDC 62135-822-84 - Carton - Label Budesonide Inhalation Suspension 0.5 mg/2 mL - NDC 62135-823-84 - Carton - Label image description image description

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Budesonide — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Budesonide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$10.81M
Claims incl. refills
53.9K
Beneficiaries
24.2K
Spend / beneficiary
$447.22
Spend / claim
$200.39
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 62135-0822-84 · Chartwell 62135-0824-01 · Chartwell →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.