FDA Orange Book
Generic for Omnipaque
Omnipaque contains iohexol. 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 Omnipaque is iohexol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 12 Omnipaque products the Orange Book lists.
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Omnipaque products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 30.2% | Marketed (Rx) | None | 0 | None |
| injectable, injection | 45.3% | Discontinued | None | 0 | None |
| solution, injection, oral | 75.5% | Marketed (Rx) | AP | 1 | AP |
| solution, injection, oral | 75.5% | Marketed (Rx) | None | 1 | AP |
| solution, injection, oral, rectal | 38.8% | Marketed (Rx) | None | 0 | None |
| solution, injection, oral, rectal | 51.8% | Marketed (Rx) | None | 0 | None |
| solution, injection, oral, rectal | 51.8% | Discontinued | None | 0 | None |
| solution, injection, oral, rectal | 64.7% | Marketed (Rx) | AP | 1 | AP |
| solution, injection, oral, rectal | 64.7% | Marketed (Rx) | None | 1 | AP |
| solution, oral | 1.9% | Marketed (Rx) | None | 0 | None |
| solution, oral | 2.6% | Marketed (Rx) | None | 0 | None |
| solution, urethral | 15.1% | Discontinued | None | 0 | None |
NDA 018956, 020608, 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 iohexol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 217737 | AP (A-rated, therapeutically equivalent) | June 25, 2026 | 75.5%, 75.5%, 64.7%, 64.7% |
Omnipaque NDC codes
Questions
Is there a generic for Omnipaque?
Yes. The generic name for Omnipaque is iohexol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 12 Omnipaque products the Orange Book lists.
What is the generic name for Omnipaque?
The active ingredient in Omnipaque is iohexol, 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.