NDC 45865-161
Metaxalone 800 mg tablet
On the label: Medsource Pharmaceuticals. It's repackaged from NDC 64980-472, made by Rising Pharma Holdings, Inc. (Metaxalone). That product's FDA listing has since ended, so its label and factories are no longer published.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Appco Pharma LLC | Piscataway, NJ, United States | Makes it and packages it | Problems found, fixed voluntarilyMay 14, 2026 · 9 inspections |
| Medsource Pharmaceuticals | Rancho Santa Margarita, CA, United States | Repackages it | Problems found, fixed voluntarilyDec 11, 2023 · 3 inspections |
Product details
- Generic drug
- Metaxalone: every company that makes it
- Form
- tablet
- Strength
- 800 mg
- Approval
- ANDA ANDA208774
- On the market since
- Sep 24, 2018
- Package NDCs
45865-161-3045865-161-60- Official label
- DailyMed (National Library of Medicine), updated Feb 26, 2024
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