NDC 0904-6936
Paliperidone 6 mg tablet, film coated, extended release
On the label: Major Pharmaceuticals. It's repackaged: Major Pharmaceuticals rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 47335-766.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Dadra, India | Makes it and tests it | Problems found, fixed voluntarilyMar 29, 2019 · 5 inspections |
Recalls
- Feb 28, 2022 · Class II · The Harvard Drug Group
Failed Dissolution Specifications
Lots: Lot #: N00522, Exp. Date 09/2022; N00618, Exp. Date 11/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Paliperidone: every company that makes it
- Form
- tablet, film coated, extended release, oral
- Strength
- 6 mg
- Approval
- ANDA ANDA205618
- On the market since
- Aug 1, 2018
- Package NDCs
0904-6936-61- Official label
- DailyMed (National Library of Medicine), updated Apr 30, 2026
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