Prescription medicine
Decitabine First approved as Dacogen
Decitabine (Dacogen) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 17 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the decitabine FDA label on DailyMed (effective August 6, 2026, Sagent Pharmaceuticals); the NDA 21790 record on Drugs@FDA; every decitabine label on DailyMed.
Highlights of the record
FDA label of August 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDecitabine 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 inte
Forms and strengths
- 50 mg
- 50 mg/10ml
- 50 mg/20ml
- 50 mg/26ml
Injection (powder) (lyophilized) for solution; kit.
On the market
- Earliest approval on file
- May 2, 2006 Dacogen, Otsuka; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first July 11, 2013; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 18 of which 17 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 2 since 2018 0 Class I among all firms' recalls; latest July 2, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 4,243 through July 30, 2026
What is decitabine used for?
From the label: indications and usageDecitabine 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 intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. […]
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (Decitabine), Sagent Pharmaceuticals, effective August 6, 2026 (SPL set 749f8d8c-e378-42a1-b94a-136b606dadb4), via openFDA; the full label on DailyMed
Is there a generic for decitabine (Dacogen)?
The FDA approved the first generic decitabine on July 11, 2013. 20 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists decitabine from 17 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2006 earliest approval on file
- 2013 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is decitabine in shortage?
No decitabine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated February 20, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Decitabine, Injection, 50 mg (NDC 50742-430-01) | Ingenus Pharmaceuticals LLC | To Be Discontinued | February 20, 2026 |
| Decitabine, Injection, 50 mg (NDC 68001-573-41) | Ingenus Pharmaceuticals LLC | To Be Discontinued | February 20, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has decitabine been recalled?
The FDA's Enforcement Report lists 3 recalls naming decitabine since 2018: 0 Class I (the most serious), 2 Class II, 1 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of decitabine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2024 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection. |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
| March 5, 2018 | Class III | InvaGen Pharmaceuticals, Inc. not a listed maker | Failed impurities/degradation specifications: Failure to water content and impurity |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the decitabine label say about other medicines?
The decitabine label names no other medicine on this site. The labels of 1 other medicine name decitabine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Decitabine), Sagent Pharmaceuticals, effective August 6, 2026 (SPL set 749f8d8c-e378-42a1-b94a-136b606dadb4), via openFDA; the full label on DailyMed
What do FAERS reports show for decitabine?
The FDA Adverse Event Reporting System holds 4,243 reports that list decitabine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,154 are coded as a death and 1,533 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Decitabine side effects
- the label's list beside FAERS reports
- Decitabine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other