NDC 43598-581
Buprenorphine and Naloxone 3 mg / 12 mg film, soluble
On the label: Dr. Reddy's Laboratories Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| LTS Lohmann Therapy Systems Corp. | West Caldwell, NJ, United States | Makes it and tests it | No problems foundFeb 1, 2024 · 9 inspections |
| Pharmaron Manufacturing Services (UK) Limited | Cramlington, United Kingdom | Makes the active ingredient | Problems found, fixed voluntarilyFeb 24, 2022 · 4 inspections |
Product details
- Generic drug
- Buprenorphine and Naloxone: every company that makes it
- Form
- film, soluble, buccal; sublingual
- Strength
- 3 mg / 12 mg
- Approval
- ANDA ANDA205806
- On the market since
- Jun 14, 2018
- Package NDCs
43598-581-0143598-581-30- Official label
- DailyMed (National Library of Medicine), updated Jan 12, 2026
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