FDA Orange Book

Is there a generic for Flector?

Flector contains diclofenac epolamine. 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 Flector (diclofenac epolamine).

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Flector products in the Orange Book

Flector products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
system, topical1.3%Marketed (Rx)None0None

NDA 021234, held by IBSA INSTITUT BIOCHIMIQUE SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Flector NDC codes

Questions

Is there a generic for Flector?

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

What is the generic name for Flector?

The active ingredient in Flector is diclofenac epolamine, 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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