NDC 60687-397
Mesalamine 1.2 g tablet, delayed release
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-711.
Where the pills inside were 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 |
Repackaging site
- American Health Packaging, Columbus, OH, United States · repackages it
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
- Oct 11, 2018
- Package NDCs
60687-397-2560687-397-95- Official label
- DailyMed (National Library of Medicine), updated Nov 22, 2024
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