FDA Orange Book
Generic for Zyflo CR
Zyflo CR contains zileuton. 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 Zyflo CR is zileuton. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Zyflo CR and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Zyflo CR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 600MG | Discontinued | None | 4 | AB |
NDA 022052, held by CHIESI USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic zileuton
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 204929 | AB (A-rated, therapeutically equivalent) | March 17, 2017 | 600MG |
| STRIDES PHARMA INTERNATIONAL AG | 212670 | AB (A-rated, therapeutically equivalent) | December 16, 2019 | 600MG |
| AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD | 211390 | AB (A-rated, therapeutically equivalent) | October 23, 2020 | 600MG |
| ANNORA PHARMA PRIVATE LTD | 215742 | AB (A-rated, therapeutically equivalent) | October 11, 2022 | 600MG |
Questions
Is there a generic for Zyflo CR?
Yes. The generic name for Zyflo CR is zileuton. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Zyflo CR?
The active ingredient in Zyflo CR is zileuton, 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.