NDC 72189-476
Aripiprazole 10 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Ascend Laboratories, LLC's NDC 67877-432.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it | No problems foundAug 30, 2019 · 6 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Aug 28, 2025 · Class II · Ascend Laboratories, LLC
Superpotent drug
Lots: Lot #: 24144162, Exp. Date 09/2027 - Mar 17, 2023 · Class II · Ascend Laboratories, LLC
Out of specification (OOS) for Spectroscopic Identification test by IR.
Lots: Lot #22143120, Exp. Date: June 2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Aripiprazole: every company that makes it
- Form
- tablet, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA207105
- On the market since
- May 30, 2023
- Package NDCs
72189-476-30- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2025
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