NDC 61919-087
Ondansetron 8 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Aurobindo Pharma Limited's NDC 65862-188.
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
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
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, film coated
- Strength
- 8 mg
- Approval
- ANDA ANDA078539
- On the market since
- Aug 29, 2019
- Package NDCs
61919-087-1061919-087-15- Official label
- DailyMed (National Library of Medicine), updated Apr 10, 2023
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