NDC 53002-0580
Ondansetron 4 mg tablet, orally disintegrating
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-157.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Recalls
- Dec 30, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Lots: Lot #: 19251311, Exp Date April 2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ondansetron: every company that makes it
- Form
- tablet, orally disintegrating
- Strength
- 4 mg
- Approval
- ANDA ANDA078152
- On the market since
- Jun 27, 2007
- Package NDCs
53002-0580-153002-0580-253002-0580-353002-0580-4- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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