NDC 68382-435
mesalamine 800 mg 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
- 800 mg
- Approval
- ANDA ANDA203286
- On the market since
- Aug 2, 2018
- Package NDCs
68382-435-2868382-435-3068382-435-77- Official label
- DailyMed (National Library of Medicine), updated Sep 17, 2026
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