Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Kvk-Tech, Inc. | Newtown, PA, United States | Makes it and packages it | Serious problems, FDA actionMar 14, 2025 · 13 inspections, 3 with FDA action |
| Patheon Pharmaceuticals Inc. | Cincinnati, OH, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilySep 26, 2025 · 15 inspections |
| Veranova, L.P. | West Deptford, NJ, United States | Makes the active ingredient | Problems found, fixed voluntarilyJan 23, 2026 · 8 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it | No problems foundNov 21, 2025 · 7 inspections |
| SpecGx LLC | Raleigh, NC, United States | Tests it | Problems found, fixed voluntarilySep 22, 2025 · 4 inspections |
Product details
- Generic drug
- Acetaminophen and Benzhydrocodone: every company that makes it
- Form
- tablet, oral
- Strength
- 325 mg / 8.16 mg
- Approval
- NDA NDA208653
- On the market since
- Feb 23, 2018
- Package NDCs
70040-0189-1- Official label
- DailyMed (National Library of Medicine), updated Jan 7, 2025
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