NDC 53217-328
Suboxone 2 mg / 8 mg film, soluble
On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC rebottles it from Indivior Inc.'s NDC 12496-1208.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aquestive Therapeutics | Portage, IN, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyJan 30, 2025 · 6 inspections |
| INDIVIOR UK Limited | Hull, United Kingdom | Makes the active ingredient and tests it | Problems found, fixed voluntarilySep 13, 2021 · 2 inspections |
| Macfarlan Smith Limited | Edinburgh, United Kingdom | Makes the active ingredient | Problems found, fixed voluntarilyNov 29, 2021 · 4 inspections |
| Siegfried AG | Zofingen, Switzerland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyFeb 14, 2025 · 6 inspections |
| SpecGx LLC | St. Louis, MO, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyOct 22, 2025 · 8 inspections |
| Veranova, L.P. | West Deptford, NJ, United States | Makes the active ingredient | Problems found, fixed voluntarilyJan 23, 2026 · 8 inspections |
| Alcami Carolinas Corporation | Wilmington, NC, United States | Tests it | Problems found, fixed voluntarilySep 26, 2025 · 11 inspections |
| Alcami Carolinas Corporation | St. Louis, MO, United States | Tests it | Problems found, fixed voluntarilyOct 4, 2024 · 7 inspections |
| Butterworth Laboratories Ltd | Teddington, United Kingdom | Tests it | Problems found, fixed voluntarilyApr 26, 2023 · 5 inspections |
| Eurofins Infinity Laboratory Group Inc. | Crown Point, IN, United States | Tests it | No problems foundMar 5, 2026 · 3 inspections |
| PPD Development, L.P. | Middleton, WI, United States | Tests it | Problems found, fixed voluntarilySep 25, 2025 · 6 inspections |
| Quotient Sciences (alnwick) Limited | Alnwick, United Kingdom | Tests it | Problems found, fixed voluntarilyAug 29, 2024 · 5 inspections |
| SGS North America Inc. | Lincolnshire, IL, United States | Tests it | Problems found, fixed voluntarilyMar 20, 2026 · 9 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it | No problems foundNov 21, 2025 · 7 inspections |
Repackaging site
- Aidarex Pharmaceuticals, Location not on file · relabels it
Product details
- Generic drug
- Buprenorphine and Naloxone: every company that makes it
- Form
- film, soluble
- Strength
- 2 mg / 8 mg
- Approval
- NDA NDA022410
- On the market since
- Sep 13, 2010
- Package NDCs
53217-328-01- Official label
- DailyMed (National Library of Medicine), updated May 31, 2018
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