Data / Drug companies / Decitabine
Decitabine: 18 companies and 22 products in the FDA NDC directory
Decitabine is listed in the FDA National Drug Code Directory by 18 companies, with 22 products in commercial distribution. 21 of the products (95.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, powder, lyophilized, for solution; kit, and the newest product started marketing on September 29, 2026.
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- Companies listing it
- 18
- Products
- 22
- Generic (ANDA) products
- 21 (95.5%)
- Application numbers
- 13
- Routes
- Intravenous
- openFDA record search
- api.fda.gov
Companies that list decitabine
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| BluePoint Laboratories | 3 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | September 29, 2026 |
| Meitheal Pharmaceuticals Inc. | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 2, 2021 |
| Novadoz Pharmaceuticals LLC | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | March 2, 2020 |
| Accord Healthcare Inc. | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | March 8, 2017 |
| Amneal Pharmaceuticals LLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | December 1, 2019 |
| Bryant Ranch Prepack | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | August 28, 2019 |
| Camber Pharmaceuticals, Inc. | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | May 10, 2024 |
| Dr. Reddy's Laboratories Inc. | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | December 5, 2014 |
| Dr. Reddy's Laboratories Limited | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 11, 2013 |
| Eugia US LLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | September 20, 2021 |
| Gland Pharma Limited | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | November 23, 2020 |
| Hikma Pharmaceuticals USA Inc. | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | April 15, 2022 |
| Mylan Institutional LLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | October 10, 2018 |
| Nivagen Pharmaceuticals, Inc. | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | December 17, 2020 |
| NorthStar RxLLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | August 17, 2020 |
| Qilu Pharmaceutical Co., Ltd. | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | April 12, 2021 |
| Sagent Pharmaceuticals | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | November 1, 2023 |
| Sun Pharmaceutical Industries, Inc. | 1 | kit | New drug applications (NDA) | January 24, 2014 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, powder, lyophilized, for solution | 21 | 95.5% |
| Kit | 1 | 4.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 21 | 95.5% |
| New drug applications (NDA) | 1 | 4.5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nucleoside Metabolic Inhibitor | 21 |
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.