NDC 72189-456
Aripiprazole 5 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-820.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hetero Labs Limited | Mahabubnagar, India | Makes it | Problems found, fixed voluntarilyAug 12, 2022 · 5 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Jan 10, 2018 · Class II · Hetero Labs, Ltd. - Unit III
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Lots: Lot #: ARI17089, ARI17090, Exp. 5/2019
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
- 5 mg
- Approval
- ANDA ANDA205064
- On the market since
- Mar 30, 2023
- Package NDCs
72189-456-30- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2025
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