FDA Orange Book
Generic for Vidaza
Vidaza contains azacitidine. 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 Vidaza is azacitidine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Vidaza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous, subcutaneous | 100MG/VIAL | Marketed (Rx) | AP | 12 | AP |
NDA 050794, held by BRISTOL-MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic azacitidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 201537 | AP (A-rated, therapeutically equivalent) | September 16, 2013 | 100MG/VIAL |
| ADAPTIS PHARMA PRIVATE LTD | 207518 | AP (A-rated, therapeutically equivalent) | September 29, 2016 | 100MG/VIAL |
| NATCO PHARMA LTD | 207234 | AP (A-rated, therapeutically equivalent) | June 23, 2017 | 100MG/VIAL |
| CIPLA LTD | 209540 | AP (A-rated, therapeutically equivalent) | May 4, 2018 | 100MG/VIAL |
| ACCORD HEALTHCARE INC | 207475 | AP (A-rated, therapeutically equivalent) | July 2, 2018 | 100MG/VIAL |
| EUROHEALTH INTERNATIONAL SARL | 209337 | AP (A-rated, therapeutically equivalent) | June 8, 2020 | 100MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 212128 | AP (A-rated, therapeutically equivalent) | November 2, 2020 | 100MG/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 215066 | AP (A-rated, therapeutically equivalent) | December 30, 2022 | 100MG/VIAL |
| JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | 215905 | AP (A-rated, therapeutically equivalent) | June 28, 2023 | 100MG/VIAL |
| MSN LABORATORIES PRIVATE LTD | 212580 | AP (A-rated, therapeutically equivalent) | May 16, 2024 | 100MG/VIAL |
| HETERO LABS LTD UNIT VI | 215765 | AP (A-rated, therapeutically equivalent) | October 15, 2024 | 100MG/VIAL |
| SOMERSET THERAPEUTICS LLC | 217453 | AP (A-rated, therapeutically equivalent) | May 20, 2025 | 100MG/VIAL |
Vidaza exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-399 | Orphan drug exclusivity | May 20, 2029 | 050794 |
Vidaza NDC codes
Questions
Is there a generic for Vidaza?
Yes. The generic name for Vidaza is azacitidine. 12 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 Vidaza?
The active ingredient in Vidaza is azacitidine, 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.