NDC 55150-183
Nicardipine Hydrochloride 25 mg per 10 mL injection, solution
On the label: AuroMedics Pharma LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Eugia Pharma Specialities Limited | Sangareddy, India | Makes it, tests it and packages it | Serious problems, FDA actionFeb 6, 2026 · 7 inspections, 2 with FDA action |
Recalls
- Feb 20, 2024 · Class II · Eugia US LLC
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Lots: Lot #: 3NC23002, Exp. Date 7/24; 3NC22013, 3NC22014, 3NC22015, 3NC22016, 3NC22017, 3NC22018, Exp. Date 2/24; 3NC22020, Exp. Date 3/24 - Feb 20, 2024 · Class II · Eugia US LLC
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Lots: Lot #: 3NC22019, Exp. Date 2/24
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nicardipine: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 25 mg per 10 mL
- Approval
- ANDA ANDA211121
- On the market since
- Apr 8, 2021
- Package NDCs
55150-183-0255150-183-11- Official label
- DailyMed (National Library of Medicine), updated Jun 23, 2023
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