FDA Orange Book
Is there a generic for Glofil-125?
Glofil-125 contains iothalamate sodium i-125. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Glofil-125 (iothalamate sodium i-125).
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Glofil-125 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 250-300uCi/ML | Marketed (Rx) | None | 0 | None |
NDA 017279, held by ISOTEX DIAGNOSTICS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Glofil-125 NDC codes
Questions
Is there a generic for Glofil-125?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Glofil-125 (iothalamate sodium i-125).
What is the generic name for Glofil-125?
The active ingredient in Glofil-125 is iothalamate sodium i-125, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.