NDC 53002-0591
Ondansetron 8 mg tablet, orally disintegrating
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-391.
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, orally disintegrating
- Strength
- 8 mg
- Approval
- ANDA ANDA090469
- On the market since
- Apr 12, 2010
- Package NDCs
53002-0591-153002-0591-253002-0591-353002-0591-4- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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