Prescription medicine
Tromethamine Brand names: Tham
Tromethamine (Tham) is a prescription medicine with an FDA approval on record since 1965. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the tromethamine FDA label on DailyMed (effective May 27, 2026, Hospira, Inc.); the NDA 13025 record on Drugs@FDA; every tromethamine label on DailyMed.
Highlights of the record
FDA label of May 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTham Solution (tromethamine injection) is indicated for the prevention and correction of metabolic acidosis.
Forms and strengths
- 3.6 g/100ml
Injection (solution).
On the market
- Earliest approval on file
- December 16, 1965 Tham, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first December 9, 2024; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 178 through July 30, 2026
What is tromethamine used for?
From the label: indications and usageTham Solution (tromethamine injection) is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease: Metabolic Acidosis Associated with Cardiac Bypass Surgery. Tham Solution has been found to be primarily beneficial in correcting metabolic acidosis which may occur during or immediately following cardiac bypass surgical procedures. Correction of Acidity of ACD Blood in Cardiac Bypass Surgery. It is well known that ACD blood is acidic and becomes more acidic on storage. Tromethamine effectively corrects this acidity. […]
Source: FDA drug label (THAM), Hospira, Inc., effective May 27, 2026 (SPL set 4af52118-c12b-4ad5-30bb-959848357e8a), via openFDA; the full label on DailyMed
Is there a generic for tromethamine (Tham)?
The FDA approved the first generic tromethamine on December 9, 2024. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tromethamine from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1965 earliest approval on file
- 2024 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tromethamine label say about other medicines?
The tromethamine label names no other medicine on this site. The labels of 5 other medicines name tromethamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name tromethamine
Source: FDA drug label (THAM), Hospira, Inc., effective May 27, 2026 (SPL set 4af52118-c12b-4ad5-30bb-959848357e8a), via openFDA; the full label on DailyMed
What do FAERS reports show for tromethamine?
The FDA Adverse Event Reporting System holds 178 reports that list tromethamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14 are coded as a death and 57 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Tromethamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other