NDC 76420-628
Ramelteon 8 mg tablet
On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. 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
- Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · repackages it and relabels it
Product details
- Generic drug
- Ramelteon: every company that makes it
- Form
- tablet, oral
- Strength
- 8 mg
- Approval
- ANDA ANDA211567
- On the market since
- Jul 23, 2019
- Package NDCs
76420-628-0176420-628-3076420-628-6076420-628-90- Official label
- DailyMed (National Library of Medicine), updated Nov 27, 2023
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