NDC 68001-313
Azacitidine 100 mg injection, powder, lyophilized, for solution
On the label: BluePoint Laboratories..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sindan-Pharma Srl | Bucharest, Romania | Makes it, tests it, packages it and labels it | No problems foundAug 2, 2024 · 7 inspections |
Recalls
- Jul 22, 2022 · Class III · Teva Pharmaceuticals USA Inc
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Lots: Lot: FE22001A, Exp 01/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Azacitidine: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous; subcutaneous
- Strength
- 100 mg
- Approval
- NDA NDA208216
- On the market since
- Jul 1, 2017
- Package NDCs
68001-313-56- Official label
- DailyMed (National Library of Medicine), updated May 26, 2025
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