FDA Orange Book
Generic for Dacogen
Dacogen contains decitabine. 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 Dacogen is decitabine. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Dacogen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | 50MG/VIAL | Discontinued | None | 16 | AP |
NDA 021790, held by OTSUKA PHARMACEUTICAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic decitabine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 203131 | AP (A-rated, therapeutically equivalent) | July 11, 2013 | 50MG/VIAL |
| SANDOZ INC | 202969 | AP (A-rated, therapeutically equivalent) | August 28, 2014 | 50MG/VIAL |
| ACCORD HEALTHCARE INC | 203475 | AP (A-rated, therapeutically equivalent) | February 27, 2017 | 50MG/VIAL |
| PHARMASCIENCE INC | 204607 | AP (A-rated, therapeutically equivalent) | May 31, 2017 | 50MG/VIAL |
| CHEMI SPA | 206033 | AP (A-rated, therapeutically equivalent) | September 22, 2017 | 50MG/VIAL |
| SAGENT PHARMACEUTICALS INC | 207100 | AP (A-rated, therapeutically equivalent) | March 16, 2018 | 50MG/VIAL |
| WOCKHARDT BIO AG | 209056 | AP (A-rated, therapeutically equivalent) | April 9, 2019 | 50MG/VIAL |
| MSN LABORATORIES PRIVATE LTD | 212265 | AP (A-rated, therapeutically equivalent) | August 28, 2019 | 50MG/VIAL |
| GLAND PHARMA LTD | 205539 | AP (A-rated, therapeutically equivalent) | November 23, 2020 | 50MG/VIAL |
| NIVAGEN PHARMACEUTICALS LLC | 212117 | AP (A-rated, therapeutically equivalent) | December 7, 2020 | 50MG/VIAL |
| QILU PHARMACEUTICAL HAINAN CO LTD | 212826 | AP (A-rated, therapeutically equivalent) | April 12, 2021 | 50MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 212959 | AP (A-rated, therapeutically equivalent) | July 2, 2021 | 50MG/VIAL |
| ZYDUS PHARMACEUTICALS USA INC | 214486 | AP (A-rated, therapeutically equivalent) | November 19, 2021 | 50MG/VIAL |
| JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | 213472 | AP (A-rated, therapeutically equivalent) | April 15, 2022 | 50MG/VIAL |
| HETERO LABS LTD UNIT VI | 215355 | AP (A-rated, therapeutically equivalent) | May 10, 2024 | 50MG/VIAL |
| SOMERSET THERAPEUTICS LLC | 217814 | AP (A-rated, therapeutically equivalent) | December 19, 2025 | 50MG/VIAL |
Questions
Is there a generic for Dacogen?
Yes. The generic name for Dacogen is decitabine. 16 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 Dacogen?
The active ingredient in Dacogen is decitabine, 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.