Quick answers
- What is Mesna used for?
- The FDA-approved label (Mesnex, Bamboo US Bidco LCC, December 10, 2025) says: “MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. MESNEX is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mesna have a boxed warning?
- No. None of the 12 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Mesna?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mesna been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Mesna?
- 8 companies list prescription products of Mesna in the FDA NDC Directory, including Baxter Healthcare Company, Bamboo US Bidco LCC and Gland Pharma Limited.
What Mesna is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. MESNEX is a cytoprotective agent indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use …
— FDA label: Mesnex, Bamboo US Bidco LCC, effective December 10, 2025. Read the full label on DailyMed →
The FDA has 12 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 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Tablet, film coated · Solution |
|---|---|
| Route | Intravenous · Oral |
| Prescription products | 12 in the FDA NDC Directory |
| Brand names | Mesnex |
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 Company5 products
- Bamboo US Bidco LCC1 product
- Gland Pharma Limited1 product
- Ingenus Pharmaceuticals, LLC1 product
- Fresenius Kabi USA, LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Eugia US LLC1 product
- Sagent Pharmaceuticals1 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 |
|---|---|---|---|
| NDA019884 MESNEX | Baxter Hlthcare | December 30, 1988 | 10, latest December 17, 2018 2018: Labeling · 2016: Manufacturing (CMC) · 2014: Labeling |
| NDA020855 MESNEX | Baxter Hlthcare | March 21, 2002 | 3, latest December 17, 2018 2018: Labeling · 2014: Labeling · 2012: Manufacturing (CMC) |
Generic approvals (6)
- ANDA075811Fresenius Kabi USA · April 26, 2001
- ANDA075739Hikma · January 9, 2004
- ANDA090913Sagent Pharms Inc · April 13, 2010
- ANDA206992Gland · December 18, 2017
- ANDA218871Ingenus Pharms LLC · January 13, 2025
- ANDA220518Eugia Pharma · January 27, 2026
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) | 142113, 204870, 352210, 899350 |
|---|---|
| SPL set ID of the quoted label | 1dd69e84-616d-fb77-e063-6394a90af2f4 |
| FDA labels (SPL) | 12 |
| FDA applications | NDA019884, NDA020855, 6 ANDA |
| Active ingredients (FDA) | MESNA |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mesnex, Bamboo US Bidco LCC, effective December 10, 2025; 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 →