NDC 72189-389
Cyclobenzaprine HCL ER 15 mg capsule, extended release
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Amneal Pharmaceuticals's NDC 0115-1436.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Adare Pharmaceuticals, Inc. | Vandalia, OH, United States | Makes it | Problems found, fixed voluntarilyFeb 25, 2025 · 8 inspections |
| Dipharma Francis Srl | Baranzate, Italy | Makes the active ingredient | Problems found, fixed voluntarilyJul 15, 2022 · 7 inspections |
| Medichem SA | Celra, Spain | Makes the active ingredient | Problems found, fixed voluntarilyJun 22, 2023 · 5 inspections |
| Sharp Packaging Services, LLC | Conshohocken, PA, United States | Packages it | No problems foundFeb 6, 2026 · 8 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it | No problems foundNov 21, 2025 · 7 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Cyclobenzaprine: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 15 mg
- Approval
- NDA authorized generic NDA021777
- On the market since
- Nov 9, 2022
- Package NDCs
72189-389-60- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2025
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