NDC 72162-2385
Roflumilast 500 ug tablet
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Micro Labs Limited's NDC 42571-259.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Micro Labs Limited | Verna, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMay 30, 2025 · 6 inspections, 1 with FDA action |
Repackaging site
- Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it
Product details
- Generic drug
- Roflumilast: every company that makes it
- Form
- tablet, oral
- Strength
- 500 ug
- Approval
- ANDA ANDA208180
- On the market since
- Oct 19, 2022
- Package NDCs
72162-2385-3- Official label
- DailyMed (National Library of Medicine), updated Aug 15, 2024
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