FDA Orange Book
Is there a generic for Favlyxa?
Favlyxa 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Favlyxa (fluorouracil).
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Favlyxa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 2.5GM/100ML (25MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 250MG/10ML (25MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 220201, held by AVYXA HOLDINGS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Favlyxa NDC codes
Questions
Is there a generic for Favlyxa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Favlyxa (fluorouracil).
What is the generic name for Favlyxa?
The active ingredient in Favlyxa 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.
More on Favlyxa and Fluorouracil
- What is Fluorouracil used for?FDA label uses
- Is Fluorouracil a controlled substance?Federal schedule
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- Generic for EfudexFDA Orange Book
- Generic for TolakFDA Orange Book
- Nucleoside Metabolic Inhibitors listFDA drug class
- NDC 83831-143Favlyxa NDC record
- NDC 83831-164Favlyxa NDC record