FDA Orange Book
Generic for Efudex
Efudex contains fluorouracil. 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 Efudex is fluorouracil. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
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Efudex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 5% | Marketed (Rx) | AB | 4 | AB |
| solution, topical | 2% | Marketed (Rx) | AT | 1 | AT |
| solution, topical | 5% | Discontinued | None | 2 | AT |
NDA 016831, held by EXTROVIS AG. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fluorouracil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TARO PHARMACEUTICAL INDUSTRIES LTD | 076526 | AT (A-rated, therapeutically equivalent) | November 5, 2003 | 2%, 5% |
| DR REDDYS LABORATORIES SA | 077524 | AB (A-rated, therapeutically equivalent) | April 11, 2008 | 5% |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 090368 | AB (A-rated, therapeutically equivalent) | March 5, 2010 | 5% |
| ACCORD HEALTHCARE INC | 214845 | AB (A-rated, therapeutically equivalent) | October 7, 2021 | 5% |
| ENCUBE ETHICALS PRIVATE LTD | 215612 | AT (A-rated, therapeutically equivalent) | November 2, 2023 | 5% |
| ENCUBE ETHICALS PRIVATE LTD | 216942 | AB (A-rated, therapeutically equivalent) | February 12, 2025 | 5% |
Efudex NDC codes
Questions
Is there a generic for Efudex?
Yes. The generic name for Efudex is fluorouracil. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
What is the generic name for Efudex?
The active ingredient in Efudex is fluorouracil, 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.