Medicine
Glofil-125 0.275 mCi/mL injection
Glofil-125 0.275 mCi/mL injection is a prescription medicine containing Iothalamate sodium i-125 for intravenous use, marketed by Iso-Tex Diagnostics, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Refrigerate the product upon receipt at 2°C to 8°C.
Key facts
- Active ingredient (INN)
- Iothalamate sodium i-125
- Brand
- Glofil-125
- Strength
- 0.275 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Iso-Tex Diagnostics
- Manufacturer
- Iso-Tex Diagnostics
- Origin register
- US FDA, United States
- Storage
- Refrigerate the product upon receipt at 2°C to 8°C.
- Cold chain
- Yes, shipped temperature controlled
- 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
- 1 May 1983
- Identifiers
- DailyMed set ID 7f250086-2837-484b-9674-e09856b34cb0NDC 50914-7729Application NDA017279
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, multi-dose in 1 box / 4 mL in 1 vial, multi-dose | 50914-7729-2 | Iso-Tex Diagnostics | 1 May 1983 |
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 12 February 1974 | 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
Clinical summary
Iothalamate sodium i-125 is a radioactive diagnostic agent indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease. It is available as injection for intravenous use. MedsAcross supplies Iothalamate sodium i-125 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 Iothalamate sodium i-125For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Glofil-125 prescribing information (Iso-Tex Diagnostics) · U.S. National Library of Medicine, DailyMed
Need Glofil-125 0.275 mCi/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.