FDA Orange Book
Generic for Isovue-300
Isovue-300 contains iopamidol. 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
Yes. The generic name for Isovue-300 is iopamidol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Isovue-300 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 61% | Marketed (Rx) | AP | 2 | AP |
| injectable, injection | 61% | Marketed (Rx) | None | 2 | AP |
NDA 018735, 020327, held by BRACCO DIAGNOSTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic iopamidol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HAINAN POLY PHARM CO LTD | 215382 | AP (A-rated, therapeutically equivalent) | February 27, 2023 | 61%, 61% |
| HAINAN POLY PHARM CO LTD | 217134 | AP (A-rated, therapeutically equivalent) | April 9, 2024 | 61%, 61% |
Isovue-300 exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-975 | New indication | October 10, 2028 | 018735 |
Isovue-300 NDC codes
Questions
Is there a generic for Isovue-300?
Yes. The generic name for Isovue-300 is iopamidol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Isovue-300?
The active ingredient in Isovue-300 is iopamidol, 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.