NDC 85534-0097
Levofloxacin 500 mg tablet, film coated
On the label: Hawaii Repack, Inc.. It's repackaged: Hawaii Repack, 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
- Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · repackages it
Product details
- Generic drug
- Levofloxacin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA201043
- On the market since
- Jun 20, 2011
- Package NDCs
85534-0097-085534-0097-185534-0097-285534-0097-385534-0097-485534-0097-585534-0097-6- Official label
- DailyMed (National Library of Medicine), updated Jul 18, 2026
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