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Data / Drug companies / Azacitidine

Azacitidine: 20 companies and 26 products in the FDA NDC directory

Azacitidine is listed in the FDA National Drug Code Directory by 20 companies, with 26 products in commercial distribution. 22 of the products (84.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, powder, lyophilized, for solution; tablet, film coated, and the newest product started marketing on August 29, 2025.

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Companies listing it
20
Products
26
Generic (ANDA) products
22 (84.6%)
Application numbers
15
Routes
Subcutaneous, Intravenous, Oral
Brand names
Onureg, Vidaza
openFDA record search
api.fda.gov

Companies that list azacitidine

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Celgene Corporation3tablet, film coated; injection, powder, lyophilized, for solutionNew drug applications (NDA)September 1, 2020
Dr. Reddy's Laboratories Inc.3injection, powder, lyophilized, for solutionGeneric drugs (ANDA)December 13, 2017
BluePoint Laboratories2injection, powder, lyophilized, for solutionNew drug applications (NDA)January 10, 2025
Meitheal Pharmaceuticals Inc.2injection, powder, lyophilized, for solutionGeneric drugs (ANDA)November 2, 2020
Accord Healthcare Inc.1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)January 9, 2019
Amneal Pharmaceuticals LLC1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)February 9, 2022
Apotex Corp.1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)January 23, 2024
Armas Pharmaceuticals Inc.1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)September 10, 2018
Camber Pharmaceuticals, Inc.1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)October 15, 2024
Civica, Inc.1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)May 16, 2024
Dr. Reddy's Laboratories Inc.1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)March 1, 2025
Eugia US LLC1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)January 3, 2023
Fresenius Kabi USA, LLC1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)March 16, 2017
Hikma Pharmaceuticals USA Inc.1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)June 8, 2020
MSN Laboratories Private Limited1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)May 16, 2024
NorthStar Rx LLC1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)May 8, 2019
Panacea Biotec Limited1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)May 6, 2019
Reliance Life Sciences Private Limited1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)July 30, 2025
Sandoz Inc1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)May 16, 2024
Somerset Therapeutics, LLC1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)August 29, 2025

Dosage forms

Dosage formProductsShare
Injection, powder, lyophilized, for solution2492.3%
Tablet, film coated27.7%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)2284.6%
New drug applications (NDA)415.4%

Pharmacologic classes

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.