NDC 61919-901
Cyclobenzaprine HCL 5 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Solco Healthcare U.S., LLC's NDC 43547-399.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Generics Bidco II LLC d/b/a Prinston Laboratories | Charlotte, NC, United States | Makes it | Problems found, fixed voluntarilySep 19, 2025 · 10 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Cyclobenzaprine: every company that makes it
- Form
- tablet, film coated
- Strength
- 5 mg
- Approval
- ANDA ANDA077797
- On the market since
- Apr 4, 2019
- Package NDCs
61919-901-3061919-901-4561919-901-82- Official label
- DailyMed (National Library of Medicine), updated Jun 6, 2023
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