FDA Orange Book
Is there a generic for Cytoxan?
Cytoxan contains cyclophosphamide. 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 Cytoxan (cyclophosphamide).
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Cytoxan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 100MG/VIAL | Discontinued | None | 0 | None |
| injectable, injection | 200MG/VIAL | Discontinued | None | 0 | None |
| tablet, oral | 25MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 012142, 012141, held by BAXTER HEALTHCARE CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cytoxan NDC codes
Questions
Is there a generic for Cytoxan?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cytoxan (cyclophosphamide).
What is the generic name for Cytoxan?
The active ingredient in Cytoxan is cyclophosphamide, 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.