NDC 53002-2350
Levofloxacin 500 mg tablet, film coated
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-537.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Mahabubnagar, India | Makes it and tests it | No problems foundJan 18, 2023 · 2 inspections |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
| Aurolife Pharma LLC | Dayton, NJ, United States | Makes it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Product details
- Generic drug
- Levofloxacin: every company that makes it
- Form
- tablet, film coated
- Strength
- 500 mg
- Approval
- ANDA ANDA201043
- On the market since
- Jun 20, 2011
- Package NDCs
53002-2350-153002-2350-353002-2350-553002-2350-753002-2350-9- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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