Prescription medicine
Iothalamate sodium i 125 First approved as Glofil-125
Iothalamate sodium i 125 (Glofil-125) is a prescription medicine with an FDA approval on record since 1974. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the iothalamate sodium i 125 FDA label on DailyMed (effective December 9, 2019, Iso-Tex Diagnostics, Inc.); the NDA 17279 record on Drugs@FDA; every iothalamate sodium i 125 label on DailyMed.
Highlights of the record
FDA label of December 9, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageGLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.
Forms and strengths
Injection (solution).
On the market
- Earliest approval on file
- February 12, 1974 Glofil-125, Isotex; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 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
What is iothalamate sodium i 125 used for?
From the label: indications and usageGLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.
FDA pharmacologic class: Radioactive Diagnostic Agent.
Source: FDA drug label (Glofil-125), NDA017279 (Isotex), as published by Iso-Tex Diagnostics, Inc., effective December 9, 2019 (SPL set 7f250086-2837-484b-9674-e09856b34cb0), via openFDA; the full label on DailyMed
Is there a generic for iothalamate sodium i 125 (Glofil-125)?
No generic iothalamate sodium i 125 is approved (Drugs@FDA, October 8, 2026).
- 1974 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What next?
- Other radioactive diagnostic agents
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other