Active ingredient
Mannitol
9 finished FDA listings contain Mannitol as their only active ingredient; 3 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- MANNITOL
- Dosage forms
- Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 8
- Strengths listed
- 10 g/100ml · 12.5 g/50ml · 20 g/100ml · 250 mg/ml
- Brand names in FDA listings
- Osmitrol
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6628
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 013684 | BAXTER HLTHCARE | 1964-06-08 | 2 |
| NDA 016269 | HOSPIRA | 1967-12-22 | 3 |
| ANDA 080677 | FRESENIUS KABI USA | 1972-08-11 | 2 |
| NDA 019603 | OTSUKA ICU MEDCL | 1987-01-08 | 1 |
| NDA 020006 | B BRAUN | 1993-07-26 | 1 |
Official labeling on DailyMed
- MANNITOL INJECTION, SOLUTION [ICU MEDICAL INC.] · version 6 · 2026-06-22
- MANNITOL INJECTION, SOLUTION [HOSPIRA, INC.] · version 23 · 2026-04-23
- MANNITOL INJECTION, SOLUTION [PROPHARMA DISTRIBUTION] · version 1 · 2025-11-17
- OSMITROL (MANNITOL) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY] · version 16 · 2025-08-18
- MANNITOL INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 6 · 2025-05-22
- MANNITOL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 4 · 2024-01-29
- MANNITOL INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] · version 21 · 2023-08-24
- MANNITOL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 4 · 2023-03-23
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.