NDC 72189-153
Ramelteon 8 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 70710-1344.
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 voluntarilyMar 24, 2023 · 5 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Ramelteon: every company that makes it
- Form
- tablet, oral
- Strength
- 8 mg
- Approval
- ANDA ANDA211567
- On the market since
- Nov 3, 2020
- Package NDCs
72189-153-30- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2025
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