Onureg is a brand name of Azacitidine, a prescription medicine. The FDA NDC Directory lists 2 Onureg products in 2 strengths and forms.

Bristol holds the FDA application for Onureg (NDA214120, approved September 1, 2020).

Is there a generic or store brand of Onureg?

Other products of Azacitidine are listed with the FDA, but none in exactly the same strength and form as a Onureg product.

Onureg (Azacitidine): maker, FDA approval and generic versions

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

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

Quick answers

What is Onureg?: Onureg is a brand name of Azacitidine, a prescription medicine. The FDA NDC Directory lists 2 Onureg products in 2 strengths and forms.
Who makes Onureg?: Bristol holds the FDA application for Onureg (NDA214120, approved September 1, 2020).
Is there a generic or store brand of Onureg?: Other products of Azacitidine are listed with the FDA, but none in exactly the same strength and form as a Onureg product.
Has Onureg been recalled?: No recall linked to Onureg products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Onureg is

Each Onureg product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Azacitidine · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
azacitidine 200 mg tablet, film coated (oral)	Onureg	None listed	DailyMed
azacitidine 300 mg tablet, film coated (oral)	Onureg	None listed	DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Azacitidine →

FDA approval

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

FDA applications of Onureg products (Drugs@FDA)
Application	Holder	First approved	Products
NDA214120	Bristol	September 1, 2020	2

Companies that list Onureg

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Onureg products.

Celgene Corporation2 products

Recalls

No recall linked to Onureg products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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Onureg