Amneal Pharmaceuticals Private Limited
Ahmedabad, India · makes it, tests it, packages it and labels it
Problems found, fixed voluntarily Last FDA inspection Jan 24, 2025. 9 inspections on record.
NDC 50436-0897
Aripiprazole 5 mg tablet
On the label: Unit Dose Services.
It's a repackaged product: Unit Dose Services rebottles it from Amneal Pharmaceuticals's NDC 65162-897.
Where the pills inside were made
Repackaging site
- Unit Dose Services, · repackages it and relabels it
Recalls
- Jan 26, 2022 · Class II · Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots: Batch AR202318
Product details
- Generic drug
- Aripiprazole: see every company that makes it
- Form
- tablet
- Strength
- 5 mg
- Approval
- ANDA ANDA204838
- On the market since
- Jun 20, 2016
- Package NDCs
50436-0897-1- Official label
- DailyMed (National Library of Medicine), updated Apr 3, 2018
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