Quick answers
- What is Budesonide used for?
- The FDA-approved label (Pulmicort Respules, AstraZeneca Pharmaceuticals LP, October 11, 2019) says: “PULMICORT RESPULES ® is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age Limitations of Use: Not indicated for the relief of acute bronchospasm 1.1 Maintenance Treatment of Asthma PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Budesonide have a boxed warning?
- The label we quote has no boxed warning, but 6 of 47 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Budesonide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Budesonide been recalled?
- FDA enforcement reports list 6 recalls of products of this medicine; the newest started May 29, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Budesonide?
- 34 companies list prescription products of Budesonide in the FDA NDC Directory, including A-S Medication Solutions, Teva Pharmaceuticals USA, Inc. and AstraZeneca Pharmaceuticals LP.
What Budesonide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PULMICORT RESPULES ® is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age Limitations of Use: Not indicated for the relief of acute bronchospasm 1.1 Maintenance Treatment of Asthma PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. …
— FDA label: Pulmicort Respules, AstraZeneca Pharmaceuticals LP, effective October 11, 2019. Read the full label on DailyMed →
The FDA has 47 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
6 of 47 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Suspension · Inhalant · Aerosol, powder · Capsule, coated pellets · Capsule, delayed release · Aerosol, foam · Capsule · Tablet, extended release · Tablet, film coated, extended release |
|---|---|
| Route | Respiratory (inhalation) · Oral · Rectal |
| Prescription products | 64 in the FDA NDC Directory |
| Brand names | Pulmicort Flexhaler, Pulmicort Respules, Uceris, Eohilia, Tarpeyo |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| budesonide 0.25 mg/2 mL inhalant | Generic | $0.6631 per mL |
| budesonide 0.25 mg/2 mL suspension | Generic | $0.6631 per mL |
| budesonide 0.5 mg/2 mL inhalant | Generic | $0.6267 per mL |
| budesonide 0.5 mg/2 mL suspension | Generic | $0.6267 per mL |
| budesonide 0.5 mg/2 mL suspension | Brand: Pulmicort Respules | $4.91 per mL |
| budesonide 1 mg/2 mL inhalant | Generic | $3.10 per mL |
| budesonide 1 mg/2 mL suspension | Generic | $3.10 per mL |
| budesonide 1 mg/2 mL suspension | Brand: Pulmicort Respules | $9.84 per mL |
| budesonide 180 ug aerosol, powder | Brand: Pulmicort Flexhaler | $253.50 per unit |
| budesonide 2 mg aerosol, foam | Generic | $9.60 per gram |
| budesonide 2 mg/10 mL suspension | Brand: Eohilia | $3.29 per mL |
| budesonide 3 mg capsule | Generic | $0.5181 per capsule |
| budesonide 3 mg capsule, coated pellets | Generic | $0.5181 per capsule |
| budesonide 3 mg capsule, delayed release | Generic | $0.5181 per capsule |
| budesonide 9 mg tablet, film coated, extended release | Generic | $15.44 per tablet |
| budesonide 90 ug aerosol, powder | Brand: Pulmicort Flexhaler | $188.52 per unit |
NADAC list of November 4, 2026; these prices took effect between January 21, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions8 products
- Teva Pharmaceuticals USA, Inc.5 products
- AstraZeneca Pharmaceuticals LP3 products
- American Health Packaging3 products
- Preferred Pharmaceuticals Inc.3 products
- Cipla USA Inc.3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Amneal Pharmaceuticals of New York LLC3 products
- Exelan Pharmaceuticals Inc.3 products
- Rubicon Holdings Inc.2 products
- Bryant Ranch Prepack2 products
- Rising Pharma Holdings, Inc.2 products
- Oceanside Pharmaceuticals2 products
- Nephron Pharmaceuticals Corporation2 products
- Chartwell RX, LLC2 products
- H2-Pharma, LLC2 products
- Padagis Israel Pharmaceuticals Ltd1 product
- Takeda Pharmaceuticals America, Inc.1 product
- Padagis US LLC1 product
- NorthStar Rx LLC1 product
- Amneal Pharmaceuticals LLC1 product
- Calliditas Therapeutics AB1 product
- Aurobindo Pharma Limited1 product
- Santarus, Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
- Remedyrepack Inc.1 product
- Golden State Medical Supply, Inc.1 product
- Cardinal Health 107, LLC1 product
- Salix Pharmaceuticals, Inc.1 product
- Lupin Pharmaceuticals, Inc.1 product
- Actavis Pharma, Inc.1 product
- Zydus Lifesciences Limited1 product
- Major Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020929 PULMICORT RESPULES | Astrazeneca | August 8, 2000 | 23, latest September 6, 2019 2019: Labeling · 2015: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
| NDA021324 ENTOCORT EC | Padagis Us | October 2, 2001 | 13, latest June 5, 2024 2024: Labeling · 2020: Labeling · 2019: Labeling |
| NDA021949 PULMICORT FLEXHALER | Cheplapharm | July 12, 2006 | 8, latest September 6, 2019 2019: Labeling · 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
| NDA203634 UCERIS | Salix | January 14, 2013 | 7, latest June 5, 2024 2024: Labeling · 2021: Labeling · 2020: Labeling |
| NDA205613 UCERIS | Salix | October 7, 2014 | 2, latest April 9, 2020 2020: Labeling · 2015: Manufacturing (CMC) |
| NDA213976 EOHILIA | Takeda Pharms USA | February 9, 2024 | 1, latest May 16, 2024 2024: Labeling |
| NDA215935 TARPEYO | Calliditas | December 15, 2021 | 3, latest June 5, 2024 2024: Labeling · 2024: Labeling · 2023: Efficacy |
Generic approvals (13)
- ANDA077519Teva Pharms · November 18, 2008
- ANDA078202Nephron · March 30, 2009
- ANDA078404Impax Labs Inc · July 31, 2012
- ANDA204548Teva Pharms USA · March 8, 2016
- ANDA206134Zydus Pharms · May 4, 2017
- ANDA206200Amneal Pharms · July 31, 2017
- ANDA205710Cipla · November 16, 2017
- ANDA205457Actavis Labs Fl Inc · July 3, 2018
- ANDA210897Lupin · November 9, 2018
- ANDA208851Mylan · September 17, 2020
- ANDA211922Sun Pharm · April 14, 2021
- ANDA215328Padagis Israel · April 12, 2023
- ANDA216667Eugia Pharma · November 29, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 29, 2026 · Class II · Ongoing · D-0607-2026
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
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactur — SUN PHARMACEUTICAL INDUSTRIES INC
-
June 30, 2025 · Class II · Ongoing · D-0541-2025
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Bouleva — Cipla USA, Inc.
-
January 8, 2024 · Class II · Ongoing · D-0275-2024
Failed Dissolution Specifications
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2 — Teva Pharmaceuticals USA, Inc
-
September 15, 2022 · Class II · Terminated · D-1545-2022
Lack of Assurance of Sterility
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Wa — CIPLA
-
January 11, 2013 · Class III · Terminated · D-198-2013
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04 — AstraZeneca LP
-
January 11, 2013 · Class III · Terminated · D-199-2013
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04 — AstraZeneca LP
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 252559, 349094, 351109, 616817, 616819, 616830, 966522, 966524, 966527, 966529 … (+9) |
|---|---|
| SPL set ID of the quoted label | 33cd9834-76df-4f26-3fa2-aab6b9eee8f2 |
| FDA labels (SPL) | 47 |
| FDA applications | NDA020929, NDA021324, NDA021949, NDA203634, NDA205613, NDA213976, NDA215935, 13 ANDA |
| Active ingredients (FDA) | BUDESONIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pulmicort Respules, AstraZeneca Pharmaceuticals LP, effective October 11, 2019; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →