NDC 53002-0601
Ondansetron Hydrochloride 8 mg tablet, film coated
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Rising Pharma Holdings, Inc.'s NDC 57237-076.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Product details
- Generic drug
- Ondansetron: every company that makes it
- Form
- tablet, film coated
- Strength
- 8 mg
- Approval
- ANDA ANDA078539
- On the market since
- Jul 31, 2007
- Package NDCs
53002-0601-153002-0601-253002-0601-353002-0601-4- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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