FDA Orange Book
Generic for Visipaque
Visipaque contains iodixanol. 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 Visipaque is iodixanol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Visipaque products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 55% | Marketed (Rx) | AP | 1 | AP |
| injectable, injection | 55% | Discontinued | None | 1 | AP |
| injectable, injection | 65.2% | Marketed (Rx) | AP | 1 | AP |
| injectable, injection | 65.2% | Marketed (Rx) | None | 1 | AP |
NDA 020351, 020808, held by GE HEALTHCARE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic iodixanol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| JIANGSU HENGRUI PHARMACEUTICALS CO LTD | 214271 | AP (A-rated, therapeutically equivalent) | May 19, 2022 | 55%, 55%, 65.2%, 65.2% |
Visipaque NDC codes
Questions
Is there a generic for Visipaque?
Yes. The generic name for Visipaque is iodixanol. 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 Visipaque?
The active ingredient in Visipaque is iodixanol, 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.