Active ingredient
Mesna
12 finished FDA listings contain Mesna as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MESNA
- Dosage forms
- Injection, Solution, Solution, Tablet, Film Coated
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 8
- Strengths listed
- 100 mg/ml · 400 mg/1
- Brand names in FDA listings
- Mesna, Mesnex
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 44
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 019884 | BAXTER HLTHCARE | 1988-12-30 | 5 |
| ANDA 075811 | FRESENIUS KABI USA | 2001-04-26 | 1 |
| NDA 020855 | BAXTER HLTHCARE | 2002-03-21 | 1 |
| ANDA 075739 | HIKMA | 2004-01-09 | 1 |
| ANDA 090913 | SAGENT PHARMS INC | 2010-04-13 | 1 |
| ANDA 206992 | GLAND | 2017-12-18 | 1 |
| ANDA 218871 | INGENUS PHARMS LLC | 2025-01-13 | 1 |
| ANDA 220518 | EUGIA PHARMA | 2026-01-27 | 1 |
Official labeling on DailyMed
- MESNEX (MESNA) TABLET, FILM COATED [BAXTER HEALTHCARE COMPANY] · version 17 · 2026-07-23
- MESNA INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY] · version 11 · 2026-05-29
- MESNA INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY] · version 17 · 2026-05-28
- MESNEX (MESNA) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY] · version 10 · 2026-05-28
- MESNEX (MESNA) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY] · version 20 · 2026-05-28
- MESNA INJECTION, SOLUTION [EUGIA US LLC] · version 1 · 2026-01-30
- MESNEX (MESNA) INJECTION, SOLUTION [BAMBOO US BIDCO LCC] · version 2 · 2025-12-15
- MESNA INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 10 · 2025-03-13
- MESNA TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC] · version 2 · 2025-01-17
- MESNA INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 5 · 2024-10-21
- MESNA INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 7 · 2023-05-04
- MESNA (MESNA INJECTION) SOLUTION [GLAND PHARMA LIMITED] · version 10 · 2022-10-10
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.