decitabine
- Product NDC
- 68083-528
- 11-digit product format
- 680830528
- Labeler code
- 68083
- Product ID
- 68083-528_39a26b24-e9d4-4974-9788-d025c51fc94f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- decitabine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA205539
- Marketing category
- ANDA
- Marketing start
- 2020-11-23
- Substance
- DECITABINE
- Active strength
- 50 mg/10mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 776B62CQ27 | DECITABINE | 2353-33-5 | DECITABINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-528-01 | 68083052801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-528-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2020-11-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| decitabine | Gland Pharma Limited | 2021-09-15 | Human Prescription Drug Label | 1 |