Quick answers
- What is Ifosfamide used for?
- The FDA-approved label (Ifosfamide, Fresenius Kabi USA, LLC, April 9, 2026) says: “Ifosfamide for Injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ifosfamide have a boxed warning?
- Yes. The FDA label for Ifosfamide has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Ifosfamide?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 16, 2026). Ask your pharmacist about alternatives.
- Has Ifosfamide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ifosfamide?
- 5 companies list prescription products of Ifosfamide in the FDA NDC Directory, including Baxter Healthcare Company, Baxter Healthcare Corporation and Hikma Pharmaceuticals USA Inc..
What Ifosfamide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ifosfamide for Injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. …
— FDA label: Ifosfamide, Fresenius Kabi USA, LLC, effective April 9, 2026. Read the full label on DailyMed →
The FDA has 2 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.
This label has a boxed warning. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Injection · Injection, solution · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 11 in the FDA NDC Directory |
| Brand names | Ifex |
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.
- Baxter Healthcare Company4 products
- Baxter Healthcare Corporation2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Meitheal Pharmaceutical Inc.2 products
- Fresenius Kabi USA, 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 |
|---|---|---|---|
| NDA019763 IFEX, IFEX/MESNEX KIT | Baxter Hlthcare | August 14, 1987 | 15, latest December 2, 2024 2024: Labeling · 2018: Labeling · 2014: Labeling |
Generic approvals (3)
- ANDA076078Fresenius Kabi USA · May 28, 2002
- ANDA076657Meitheal · April 4, 2007
- ANDA076619Hikma · June 29, 2011
Shortage status
Current shortage · updated October 16, 2026 · first posted June 12, 2026
| Product | IFEX, Injection, 3 g/60 mL (NDC 0338-3993-01) |
|---|---|
| Availability | Unavailable |
| Reason given | Requirements related to complying with good manufacturing practices |
| Company | Baxter Healthcare |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1791593, 1791597, 1791599 |
|---|---|
| SPL set ID of the quoted label | a311a947-7b78-4226-bfe0-f4aa0be20e27 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA019763, 3 ANDA |
| Active ingredients (FDA) | IFOSFAMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ifosfamide, Fresenius Kabi USA, LLC, effective April 9, 2026; 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 →