NDC 68382-452
Mesalamine 0.375 g capsule, extended release
On the label: Zydus Pharmaceuticals (USA) Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyMar 24, 2023 · 5 inspections |
Product details
- Generic drug
- Mesalamine: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 0.375 g
- Approval
- ANDA ANDA208954
- On the market since
- Aug 13, 2021
- Package NDCs
68382-452-19- Official label
- DailyMed (National Library of Medicine), updated Oct 22, 2026
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