NDC 54092-100
Mesalamine 1.2 g tablet, delayed release
On the label: Takeda Pharmaceuticals America, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cosmo SpA | Lainate, Italy | Makes it and tests it | Problems found, fixed voluntarilyNov 11, 2022 · 5 inspections |
| PharmaZell GmbH | Raubling, Germany | Makes the active ingredient | Problems found, fixed voluntarilyJun 30, 2022 · 4 inspections |
| Pharmazell (India) Private Limited | Anakapalli, India | Makes the active ingredient | Problems found, fixed voluntarilyFeb 7, 2025 · 4 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it and labels it | No problems foundNov 21, 2025 · 7 inspections |
Product details
- Generic drug
- Mesalamine: every company that makes it
- Form
- tablet, delayed release, oral
- Strength
- 1.2 g
- Approval
- NDA authorized generic NDA022000
- On the market since
- Aug 29, 2017
- Package NDCs
54092-100-01- Official label
- DailyMed (National Library of Medicine), updated Oct 23, 2026
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