NDC 76420-534
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg / 8 mg tablet
On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from Accord Healthcare Inc.'s NDC 16729-550.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Wes Pharma Inc | Westminster, MD, United States | Makes it | Problems found, fixed voluntarilyNov 20, 2025 · 7 inspections |
Repackaging site
- Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · relabels it
Product details
- Generic drug
- Buprenorphine and Naloxone: every company that makes it
- Form
- tablet, sublingual
- Strength
- 2 mg / 8 mg
- Approval
- ANDA ANDA209069
- On the market since
- Jan 22, 2021
- Package NDCs
76420-534-30- Official label
- DailyMed (National Library of Medicine), updated Jan 27, 2023
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