NDC 84549-464
Nalbuphine Hydrochloride 10 mg per 1 mL injection, solution
On the label: ProPharma Distribution. It's repackaged: ProPharma Distribution rebottles it from Hospira, Inc.'s NDC 0409-1464.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. | Rocky Mount, NC, United States | Makes it, tests it, packages it and labels it | No problems foundFeb 7, 2025 · 11 inspections, 3 with FDA action |
Repackaging site
- ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it
Recalls
- Nov 21, 2012 · Class II · Hospira, Inc.
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
Lots: Lot #: 11-293-DK, Exp 05/01/13
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nalbuphine: every company that makes it
- Form
- injection, solution, intramuscular; intravenous; subcutaneous
- Strength
- 10 mg per 1 mL
- Approval
- ANDA ANDA070915
- On the market since
- Jul 19, 2005
- Package NDCs
84549-464-01- Official label
- DailyMed (National Library of Medicine), updated Dec 18, 2025
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