NDC 63323-626
Sodium chloride 450 mg per 100 mL injection, solution
On the label: Fresenius Kabi, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi Deutschland GmbH | Friedberg, Germany | Makes it and tests it | Problems found, fixed voluntarilyDec 21, 2023 · 4 inspections |
| Fresenius Kabi USA, LLC | Wilson, NC, United States | Makes it and tests it | Problems found, fixed voluntarilyFeb 13, 2026 · 5 inspections |
| HP Halden Pharma AS | Halden, Norway | Makes it, tests it and packages it | Problems found, fixed voluntarilyMay 10, 2023 · 7 inspections |
Recalls
- Mar 11, 2026 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Lots: Batch # 6402413, Exp Date: 02/29/2028
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sodium Cation: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 450 mg per 100 mL
- Approval
- ANDA ANDA208122
- On the market since
- Jul 23, 2018
- Package NDCs
63323-626-0063323-626-0163323-626-0263323-626-0363323-626-0463323-626-0563323-626-1063323-626-2563323-626-5063323-626-55- Official label
- DailyMed (National Library of Medicine), updated Jul 22, 2024
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