NDC 68382-711
mesalamine 1.2 g tablet, delayed 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 voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Product details
- Generic drug
- Mesalamine: every company that makes it
- Form
- tablet, delayed release, oral
- Strength
- 1.2 g
- Approval
- ANDA ANDA091640
- On the market since
- Jun 19, 2017
- Package NDCs
68382-711-1968382-711-64- Official label
- DailyMed (National Library of Medicine), updated Oct 27, 2026
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