FDA Orange Book
Is there a generic for Zoladex?
Zoladex contains goserelin acetate. 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 Zoladex (goserelin acetate).
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Zoladex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| implant, implantation | EQ 10.8MG BASE | Marketed (Rx) | None | 0 | None |
| implant, implantation | EQ 3.6MG BASE | Marketed (Rx) | None | 0 | None |
NDA 020578, 019726, held by TERSERA THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zoladex NDC codes
Questions
Is there a generic for Zoladex?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zoladex (goserelin acetate).
What is the generic name for Zoladex?
The active ingredient in Zoladex is goserelin acetate, 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.