NDC 67046-953
Phenobarbital 64.8 mg tablet
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from ENDO USA, Inc.'s NDC 0603-5167.
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, packages it and labels it | Problems found, fixed voluntarilySep 19, 2025 · 10 inspections, 1 with FDA action |
| Generics Bidco II LLC d/b/a Prinston Laboratories | Charlotte, NC, United States | Makes it and tests it | Problems found, fixed voluntarilySep 19, 2025 · 10 inspections, 1 with FDA action |
Repackaging site
- Coupler Enterprises, Location not on file · repackages it
Product details
- Generic drug
- Phenobarbital: every company that makes it
- Form
- tablet
- Strength
- 64.8 mg
- Approval
- unapproved drug other
- On the market since
- Dec 1, 2001
- Package NDCs
67046-953-30- Official label
- DailyMed (National Library of Medicine), updated Sep 3, 2018
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