FDA Orange Book
Generic for Gemzar
Gemzar 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
Yes. The generic name for Gemzar is gemcitabine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Gemzar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 1GM BASE/VIAL | Discontinued | None | 8 | AP |
| injectable, injection | EQ 200MG BASE/VIAL | Discontinued | None | 8 | AP |
NDA 020509, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic gemcitabine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 091365 | AP (A-rated, therapeutically equivalent) | July 25, 2011 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL |
| FRESENIUS KABI USA LLC | 090799 | AP (A-rated, therapeutically equivalent) | July 25, 2011 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL |
| HOSPIRA WORLDWIDE, INC | 078339 | AP (A-rated, therapeutically equivalent) | July 25, 2011 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 078433 | AP (A-rated, therapeutically equivalent) | July 25, 2011 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL |
| TEYRO LABS PRIVATE LTD | 078759 | AP (A-rated, therapeutically equivalent) | July 25, 2011 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL |
| JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | 202485 | AP (A-rated, therapeutically equivalent) | May 7, 2013 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL |
| GLAND PHARMA LTD | 204520 | AP (A-rated, therapeutically equivalent) | January 5, 2016 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL |
| ADAPTIS PHARMA PRIVATE LTD | 207575 | AP (A-rated, therapeutically equivalent) | February 22, 2019 | EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL |
Questions
Is there a generic for Gemzar?
Yes. The generic name for Gemzar is gemcitabine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Gemzar?
The active ingredient in Gemzar 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.