Active ingredient
Tromethamine
3 finished FDA listings contain Tromethamine as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- TROMETHAMINE
- Dosage forms
- Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 3.6 g/100ml
- Brand names in FDA listings
- Tham
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10865
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 013025 | HOSPIRA | 1965-12-16 | 1 |
| ANDA 211558 | B BRAUN MEDICAL | 2024-12-09 | 1 |
| ANDA 213116 | MILLA PHARMS | 2024-12-31 | 1 |
Official labeling on DailyMed
- THAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.] · version 21 · 2026-05-28
- TROMETHAMINE INJECTION, SOLUTION [MILLA PHARMACEUTICALS INC.] · version 3 · 2026-01-09
- TROMETHAMINE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] · version 7 · 2025-09-29
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.