Quick answers
- What is Ultane?
- Ultane is a brand name of Sevoflurane, a prescription medicine. The FDA NDC Directory lists 1 Ultane product in 1 strength and form.
- Who makes Ultane?
- Abbvie holds the FDA application for Ultane (NDA020478, approved June 7, 1995).
- Is there a generic or store brand of Ultane?
- Yes. The FDA NDC Directory lists 8 other products with the same active ingredients, strength and form as a Ultane product, 8 of them generic. Ask your pharmacist whether one is right for you.
- Has Ultane been recalled?
- FDA enforcement reports list 1 recall of Ultane products; the newest started January 22, 2018. A recall usually concerns specific lots, not every product.
What Ultane is
Each Ultane 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.
Sevoflurane · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| sevoflurane 250 mL/250 mL liquid (respiratory (inhalation)) | Ultane | 8 products, 6 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sevoflurane →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020478 | Abbvie | June 7, 1995 | 1 |
Companies that list Ultane
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Ultane products.
- AbbVie Inc.1 product
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 22, 2018 · Class III · Terminated · D-0412-2018
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51 — AbbVie Inc.
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.