NDC 43598-305
Azacitidine 100 mg injection, powder, lyophilized, for solution
On the label: Dr. Reddy's Laboratories Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| DR Reddy's Laboratories Limited | Srikakulam, India | Makes it and tests it | Problems found, fixed voluntarilyJul 18, 2025 · 1 inspection |
| Dr.reddy's Laboratories Limited | Visakhapatnam, India | Makes it and tests it | Problems found, fixed voluntarilyMay 17, 2024 · 9 inspections, 2 with FDA action |
Recalls
- Jan 19, 2022 · Class III · Dr. Reddy's Laboratories, Inc.
Failed stability specifications
Lots: Lot #: H200101, H200102, H200099, H200100 & H200106, Exp 8/1/2023; H210015, H210014 & H210013, Exp 11/1/2023; H210086, Exp 12/1/2023; H210130, Exp 1/1/2024; H210171, H210172, H210173, H210174, Exp 2/1/2024; H210196 & H210197, Exp 3/1/2024; H210283 & H210282, Exp 4/1/2024; H210382, H210381, H210419 …
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
- ANDA ANDA201537
- On the market since
- Sep 19, 2013
- Package NDCs
43598-305-62- Official label
- DailyMed (National Library of Medicine), updated Jul 31, 2024
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