Medicine
Tromethamine 18 g/500 mL injection
Tromethamine 18 g/500 mL injection is a generic prescription medicine for intravenous use, made by 2 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Protect from freezing. Store at 20 to 25°C (68 to 77°F).
Key facts
- Active ingredient (INN)
- Tromethamine
- Brand
- Sold under the generic name
- Strength
- 18 g/500 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 24 bags of 500 mL, 6 bottles of 500 mL
- Manufacturers
- B. Braun MedicalMilla Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 20 to 25°C (68 to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 December 2024
- Identifiers
- RxCUI 198412DailyMed set ID 082b1104-502b-47af-95bf-0dbf2422990e, 57db5686-7f7f-4999-87e3-e1cbbda4a98dNDC 71357-001, 0264-8031Application ANDA213116, ANDA211558
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 24 bag in 1 case / 500 mL in 1 bag | 0264-8031-10 | B. Braun Medical | 27 August 2025 |
| 6 bottle, glass in 1 case / 500 mL in 1 bottle, glass | 71357-001-01 | Milla Pharmaceuticals | 31 December 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 16 December 1965 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Tromethamine 18 g/500 mL injection.
Clinical summary
Tromethamine is a prescription medicine indicated for the prevention and correction of metabolic acidosis. It is available as injection for intravenous use. MedsAcross supplies Tromethamine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about TromethamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- THAM prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
Need Tromethamine 18 g/500 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.