NDC 84549-117
Fluorouracil 50 mg per 1 mL injection, solution
On the label: ProPharma Distribution. It's repackaged: ProPharma Distribution rebottles it from Fresenius Kabi, LLC's NDC 63323-117.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Repackaging site
- ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it
Recalls
- Jun 28, 2019 · Class I · Fresenius Kabi USA, LLC
Presence of Particulate Matter; glass particulates
Lots: Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluorouracil: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 50 mg per 1 mL
- Approval
- ANDA ANDA040279
- On the market since
- Jan 2, 2017
- Package NDCs
84549-117-10- Official label
- DailyMed (National Library of Medicine), updated Nov 7, 2025
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