Prescription medicine
Azacitidine Brand names: Onureg, Vidaza
Azacitidine (Vidaza) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 20 generic labelers.
- Generic listed
- In shortage
Check it at the source: the azacitidine FDA label on DailyMed (effective January 29, 2024, Celgene Corporation); the NDA 50794 record on Drugs@FDA; every azacitidine label on DailyMed.
Highlights of the record
FDA label of January 29, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of:
Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T),
Forms and strengths
- 100 mg
- 200 mg
- 300 mg
- 100 mg/4ml
- 100 mg/50ml
- 100 mg/30ml
Injection (powder) (lyophilized) for solution; film-coated tablet.
On the market
- Earliest approval on file
- May 19, 2004 Vidaza, Bristol-Myers; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first September 16, 2013; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 21 of which 20 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 3, 2030 Onureg tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 4 of 9 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 8 since 2019 0 Class I among all firms' recalls; latest June 24, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 29,495 through July 30, 2026
What is azacitidine used for?
From the label: indications and usageVIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of:
Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). ( 1.1 )
Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). […]
Conditions named in the indications of azacitidine's FDA labels, with every medicine labeled for each:
From other azacitidine labelsLeukemia, lymphoma and myeloma: ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction …
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (VIDAZA), NDA050794 (Bristol-Myers), as published by Celgene Corporation, effective January 29, 2024 (SPL set 3495a71a-cc04-4776-851f-f185956f32af), via openFDA; the full label on DailyMed
Is there a generic for azacitidine (Vidaza)?
The FDA approved the first generic azacitidine on September 16, 2013. 15 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists azacitidine from 20 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Vidaza injection; a patent listed only for Onureg tablets runs to June 3, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2004 earliest approval on file
- 2013 first generic approved
- 2030 last listed patent
- 2020 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is azacitidine in shortage?
The FDA Drug Shortage Database lists 4 of 9 azacitidine presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on December 18, 2020. 5 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Azacitidine, Injection, 100 mg (NDC 16729-306-10) | Accord Healthcare Inc. | Current | October 3, 2026 |
| Azacitidine, Injection, 100 mg (NDC 43598-305-62) | Dr. Reddy's Laboratories, Inc. | Current | September 29, 2026 |
| Azacitidine, Injection, 100 mg (NDC 68001-313-56) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Azacitidine, Injection, 100 mg (NDC 72485-201-01) | Armas Pharmaceuticals Inc | Current | June 8, 2026 |
| Azacitidine, Injection, 100 mg/ Vial (NDC 0143-9606-01) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Azacitidine, Injection, 100 mg/30 mL (NDC 63323-771-39) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Azacitidine, Injection, 100 mg/30 mL (NDC 71288-115-30) | Meitheal Pharmaceuticals, Inc. | Current | August 27, 2026 |
| Azacitidine, Injection, 100 mg/4 mL (NDC 55150-393-01) | Eugia US LLC | Current | October 2, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has azacitidine been recalled?
The FDA's Enforcement Report lists 9 recalls naming azacitidine since 2019: 0 Class I (the most serious), 5 Class II, 4 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of azacitidine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 24, 2026 | Class II | Reliance Life Sciences Private Limited | Lack of Sterility Assurance |
| July 27, 2022 | Class III | Amerisource Health Services LLC | Subpotent Drug |
| July 22, 2022 | Class III | Teva Pharmaceuticals USA Inc | Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification. |
| January 19, 2022 | Class III | Dr. Reddy's Laboratories, Inc. | Failed stability specifications |
| December 14, 2020 | Class II | CIPLA | cGMP deviations: Vials may not be sealed correctly affecting sterility. |
| December 8, 2020 | Class II | Shilpa Medicare Limited | CGMP Deviations |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the azacitidine label say about other medicines?
The azacitidine label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name azacitidine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | warnings and precautions | Tumor lysis syndrome may occur despite concomitant use of allopurinol. |
| Etoposide | warnings and precautions | In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to <20 mEq/L in association with an alkaline urine and hypokalemia (serum potassium <3 mEq/L) developed in 5 patients with CML treated with azacitidine and etoposide. |
Other labels that name azacitidine
Source: FDA drug label (VIDAZA), NDA050794 (Bristol-Myers), as published by Celgene Corporation, effective January 29, 2024 (SPL set 3495a71a-cc04-4776-851f-f185956f32af), via openFDA; the full label on DailyMed
What do FAERS reports show for azacitidine?
The FDA Adverse Event Reporting System holds 29,495 reports that list azacitidine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10,775 are coded as a death and 12,837 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Azacitidine side effects
- the label's list beside FAERS reports
- Azacitidine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other