Quick answers
- What is ProAir Digihaler?
- ProAir Digihaler is a brand name of Albuterol sulfate, a prescription medicine. The FDA NDC Directory lists 1 ProAir Digihaler product in 1 strength and form.
- Who makes ProAir Digihaler?
- Teva Branded Pharm holds the FDA application for ProAir Digihaler (NDA205636, approved March 31, 2015).
- Is there a generic or store brand of ProAir Digihaler?
- Yes. The FDA NDC Directory lists 11 other products with the same active ingredients, strength and form as a ProAir Digihaler product, 11 of them generic. Ask your pharmacist whether one is right for you.
- Has ProAir Digihaler been recalled?
- No recall linked to ProAir Digihaler products (by their NDC code or label) appears in the FDA enforcement reports we use.
What ProAir Digihaler is
Each ProAir Digihaler 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.
Albuterol sulfate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| albuterol sulfate 90 ug inhalant (respiratory (inhalation)) | ProAir Digihaler | 11 products, 9 companies | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Albuterol sulfate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA205636 | Teva Branded Pharm | March 31, 2015 | 1 |
Companies that list ProAir Digihaler
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of ProAir Digihaler products.
- Teva Respiratory, LLC1 product
Recalls
No recall linked to ProAir Digihaler products (by their NDC code or label) appears in the FDA enforcement reports.
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.