FDA Orange Book
Is there a generic for Avgemsi?
Avgemsi contains gemcitabine. 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 Avgemsi (gemcitabine).
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Avgemsi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) | Discontinued | None | 0 | None |
| solution, intravenous | EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 219920, 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.
Avgemsi NDC codes
Questions
Is there a generic for Avgemsi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Avgemsi (gemcitabine).
What is the generic name for Avgemsi?
The active ingredient in Avgemsi is gemcitabine, 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.