NDC 72189-095
Oxycodone Hydrochloride 5 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 43386-432.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Novel Laboratories, Inc. | Somerset, NJ, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyApr 17, 2026 · 15 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Dec 29, 2021 · Class III · Lupin Pharmaceuticals Inc.
Out-of-specification impurity test result observed at 18-month long term stability time point.
Lots: Lot # S000268, Exp. date January 2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Oxycodone: every company that makes it
- Form
- tablet, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA204021
- On the market since
- Jun 15, 2020
- Package NDCs
72189-095-3072189-095-6072189-095-90- Official label
- DailyMed (National Library of Medicine), updated Jun 5, 2025
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