Quick answers
- What is Isoflurane used for?
- The FDA-approved label (Forane, Baxter Healthcare Corporation, December 9, 2024) says: “FORANE (isoflurane, USP) may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. FORANE, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general anesthesia.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Isoflurane have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Isoflurane?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Isoflurane been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Isoflurane?
- 5 companies list prescription products of Isoflurane in the FDA NDC Directory, including Piramal Critical Care Inc, Mullan Pharmaceutical Inc. and Shandong New Time Pharmaceutical Co., Ltd..
What Isoflurane is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FORANE (isoflurane, USP) may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia. FORANE, a general anesthetic, is an inhalation agent indicated for induction and maintenance of general anesthesia.
— FDA label: Forane, Baxter Healthcare Corporation, effective December 9, 2024. Read the full label on DailyMed →
The FDA has 8 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.
0 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Liquid · Inhalant |
|---|---|
| Route | Respiratory (inhalation) |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Isoflurane, (Volatile for Inhalation), Terrell, Forane |
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.
- Piramal Critical Care Inc4 products
- Mullan Pharmaceutical Inc.2 products
- Shandong New Time Pharmaceutical Co., Ltd.2 products
- Baxter Healthcare Corporation1 product
- Halocarbon Life Sciences, LLC1 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 |
|---|---|---|---|
| NDA017624 FORANE | Baxter Hlthcare | December 18, 1979 | 35, latest December 9, 2024 2024: Labeling · 2022: Labeling · 2021: Labeling |
Generic approvals (4)
- ANDA074416Piramal Critical · September 30, 1994
- ANDA074502Piramal Pharma · June 27, 1995
- ANDA075225Halocarbon Prods · October 20, 1999
- ANDA216527Shandong · November 4, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 542347, 542355, 542358 |
|---|---|
| SPL set ID of the quoted label | 3d30eb8d-a62e-475f-926b-78ba63bee9c8 |
| FDA labels (SPL) | 8 |
| FDA applications | NDA017624, 4 ANDA |
| Active ingredients (FDA) | ISOFLURANE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Forane, Baxter Healthcare Corporation, effective December 9, 2024; 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 →