FDA Orange Book

Is there a generic for Zueino?

Zueino contains diclofenac. 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 Zueino (diclofenac).

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Zueino products in the Orange Book

Zueino products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, intravenous37.5MG/ML (37.5MG/ML)Marketed (Rx)None0None

NDA 218379, held by ADVENTAPHARMA DWC LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Questions

Is there a generic for Zueino?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Zueino (diclofenac).

What is the generic name for Zueino?

The active ingredient in Zueino is diclofenac, 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.

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