Quick answers
- What is Tromethamine used for?
- The FDA-approved label (Tham, Hospira, Inc., May 27, 2026) says: “Tham 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tromethamine have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tromethamine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tromethamine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tromethamine?
- 3 companies list prescription products of Tromethamine in the FDA NDC Directory, including Hospira, Inc., Milla Pharmaceuticals Inc. and B. Braun Medical Inc..
What Tromethamine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Tham 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. …
— FDA label: Tham, Hospira, Inc., effective May 27, 2026. Read the full label on DailyMed →
The FDA has 3 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 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Tham |
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.
- Hospira, Inc.1 product
- Milla Pharmaceuticals Inc.1 product
- B. Braun Medical Inc.1 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 |
|---|---|---|---|
| NDA013025 THAM, THAM-E | Hospira | December 16, 1965 | 27, latest November 8, 2013 2013: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2006: Manufacturing (CMC) |
Generic approvals (2)
- ANDA211558B Braun Medical · December 9, 2024
- ANDA213116Milla Pharms · December 31, 2024
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) | 198412 |
|---|---|
| SPL set ID of the quoted label | 4af52118-c12b-4ad5-30bb-959848357e8a |
| FDA labels (SPL) | 3 |
| FDA applications | NDA013025, 2 ANDA |
| Active ingredients (FDA) | TROMETHAMINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tham, Hospira, Inc., effective May 27, 2026; 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 →