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Prescription medicine · generic available

Azacitidine

Brand names: Onureg, Vidaza

Drug class: Nucleoside Metabolic Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
Current shortageFDA shortage list
4Recalls (FDA reports)
20Companies
2004First FDA approval on file

Quick answers

What is Azacitidine used for?
The FDA-approved label (Vidaza, Celgene Corporation, January 29, 2024) says: “VIDAZA 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Azacitidine have a boxed warning?
No. None of the 26 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Azacitidine?
The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 20, 2026). Ask your pharmacist about alternatives.
Has Azacitidine been recalled?
FDA enforcement reports list 4 recalls of products of this medicine; the newest started July 22, 2022 (Class III). A recall usually concerns specific lots, not every product.
Who makes Azacitidine?
20 companies list prescription products of Azacitidine in the FDA NDC Directory, including Dr. Reddy's Laboratories Inc., Celgene Corporation and Meitheal Pharmaceuticals Inc..

What Azacitidine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

VIDAZA 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 …

— FDA label: Vidaza, Celgene Corporation, effective January 29, 2024. Read the full label on DailyMed →

The FDA has 26 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 26 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, powder, lyophilized, for solution · Tablet, film coated
RouteSubcutaneous · Intravenous · Oral
Prescription products27 in the FDA NDC Directory
Brand namesOnureg, Vidaza

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA050794
VIDAZA		 Bristol-MyersMay 19, 2004 19, latest June 28, 2024
2024: Labeling · 2022: Labeling · 2022: Efficacy
NDA208216
AZACITIDINE		 Actavis LLCApril 29, 2016 5, latest December 19, 2024
2024: Labeling · 2023: Labeling · 2020: Labeling
NDA214120
ONUREG		 BristolSeptember 1, 2020 2, latest April 9, 2026
2026: Efficacy · 2021: Manufacturing (CMC)

Generic approvals (12)

Shortage status

Current shortage · updated October 20, 2026 · first posted December 18, 2020

ProductAzacitidine, Injection, 100 mg (NDC 43598-305-62)
AvailabilityAvailable
CompanyDr. Reddy's Laboratories, Inc.

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. July 22, 2022 · Class III · Terminated · D-1334-2022

    Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

    Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56 — Teva Pharmaceuticals USA Inc

  2. January 19, 2022 · Class III · Terminated · D-0576-2022

    Failed stability specifications

    Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62 — Dr. Reddy's Laboratories, Inc.

  3. January 19, 2022 · Class III · Terminated · D-0575-2022

    Failed stability specifications

    Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62 — Dr. Reddy's Laboratories, Inc.

  4. December 8, 2020 · Class II · Terminated · D-0122-2021

    CGMP Deviations

    Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas — Shilpa Medicare Limited

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)485246, 545206, 2396764, 2396770, 2396772, 2396774
SPL set ID of the quoted label3495a71a-cc04-4776-851f-f185956f32af
FDA labels (SPL)26
FDA applicationsNDA050794, NDA208216, NDA214120, 12 ANDA
Active ingredients (FDA)AZACITIDINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Vidaza, Celgene Corporation, effective January 29, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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