NDC 36000-364
regadenoson 0.08 mg per 1 mL injection, solution
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Gland Pharma Limited | Hyderabad, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJul 25, 2024 · 7 inspections |
| Simtra US LLC | Bloomington, IN, United States | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilySep 24, 2024 · 12 inspections |
Recalls
- Oct 30, 2024 · Class II · Baxter Healthcare Corporation
Labeling: Missing Label
Lots: Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Regadenoson: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 0.08 mg per 1 mL
- Approval
- ANDA ANDA217455
- On the market since
- May 23, 2023
- Package NDCs
36000-364-01- Official label
- DailyMed (National Library of Medicine), updated Sep 25, 2024
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