Quick answers
- What is Decitabine used for?
- The FDA-approved label (Decitabine, BluePoint Laboratories, August 20, 2026) says: “Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Decitabine have a boxed warning?
- No. None of the 21 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Decitabine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Decitabine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Decitabine?
- 17 companies list prescription products of Decitabine in the FDA NDC Directory, including BluePoint Laboratories, Meitheal Pharmaceuticals Inc. and Novadoz Pharmaceuticals LLC.
What Decitabine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and …
— FDA label: Decitabine, BluePoint Laboratories, effective August 20, 2026. Read the full label on DailyMed →
The FDA has 21 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 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 20 in the FDA NDC Directory |
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.
- BluePoint Laboratories3 products
- Meitheal Pharmaceuticals Inc.2 products
- Novadoz Pharmaceuticals LLC2 products
- NorthStar Rx LLC1 product
- Camber Pharmaceuticals, Inc.1 product
- Bryant Ranch Prepack1 product
- Nivagen Pharmaceuticals, Inc.1 product
- Qilu Pharmaceutical Co., Ltd.1 product
- Eugia US LLC1 product
- Sagent Pharmaceuticals1 product
- Amneal Pharmaceuticals LLC1 product
- Dr. Reddy's Laboratories Limited1 product
- Mylan Institutional LLC1 product
- Accord Healthcare Inc.1 product
- Gland Pharma Limited1 product
- Dr. Reddy's Laboratories Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (12)
- ANDA203131DR Reddys · July 11, 2013
- ANDA203475Accord Hlthcare · February 27, 2017
- ANDA204607Pharmascience Inc · May 31, 2017
- ANDA206033Chemi Spa · September 22, 2017
- ANDA212265Msn · August 28, 2019
- ANDA205539Gland · November 23, 2020
- ANDA212117Nivagen · December 7, 2020
- ANDA212826Qilu Pharm Hainan · April 12, 2021
- ANDA212959Meitheal · July 2, 2021
- ANDA214569Eugia Pharma · September 20, 2021
- ANDA213472Jiangsu Hansoh Pharm · April 15, 2022
- ANDA215355Hetero Labs Ltd Vi · May 10, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 636631 |
|---|---|
| SPL set ID of the quoted label | 5975fa81-1e29-4d56-e063-6394a90a9cd5 |
| FDA labels (SPL) | 21 |
| FDA applications | 12 ANDA |
| Active ingredients (FDA) | DECITABINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Decitabine, BluePoint Laboratories, effective August 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →