Quick answers
- What is Pulmicort Respules?
- Pulmicort Respules is a brand name of Budesonide, a prescription medicine. The FDA NDC Directory lists 3 Pulmicort Respules products in 3 strengths and forms.
- Who makes Pulmicort Respules?
- Astrazeneca holds the FDA application for Pulmicort Respules (NDA020929, approved August 8, 2000).
- Is there a generic or store brand of Pulmicort Respules?
- Yes. The FDA NDC Directory lists 21 other products with the same active ingredients, strength and form as a Pulmicort Respules product, 21 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Pulmicort Respules?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Pulmicort Respules strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Pulmicort Respules been recalled?
- FDA enforcement reports list 2 recalls of Pulmicort Respules products; the newest started January 11, 2013. A recall usually concerns specific lots, not every product.
What Pulmicort Respules is
Each Pulmicort Respules product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Budesonide · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| budesonide 0.25 mg/2 mL suspension (respiratory (inhalation)) | Pulmicort Respules | 8 products, 7 companies | DailyMed |
| budesonide 0.5 mg/2 mL suspension (respiratory (inhalation)) | Pulmicort Respules | 11 products, 10 companies | DailyMed |
| budesonide 1 mg/2 mL suspension (respiratory (inhalation)) | Pulmicort Respules | 2 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Budesonide →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020929 | Astrazeneca | August 8, 2000 | 3 |
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 0.5 mg/2 mL suspension | Brand: Pulmicort Respules | $4.91 per mL Generic of the same strength and form: $0.6267 per mL |
| budesonide 1 mg/2 mL suspension | Brand: Pulmicort Respules | $9.84 per mL Generic of the same strength and form: $3.10 per mL |
NADAC list of November 4, 2026; these prices took effect between April 22, 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 Pulmicort Respules
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Pulmicort Respules products.
- AstraZeneca Pharmaceuticals LP3 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.