Buprenorphine And Naloxone 00378-8768
Product NDC
00378-8768- Manufacturer
- Mylan Pharmaceuticals Inc.
- Dosage Form
- Film
- Route
- Buccal And Sublingual
- Product Type
- Human Prescription Drug
- DEA Schedule
- Schedule CIII
- Marketing Start
- February 20, 2019
- Listing Expires
- December 31, 2027
- Application
- ANDA207607
Active Ingredients
| Ingredient | Strength |
|---|---|
| Buprenorphine Hydrochloride | 12 mg/1 |
| Naloxone Hydrochloride Dihydrate | 3 mg/1 |
Drug Class
Opioid Antagonist [EPC]Opioid Antagonists [MoA]Partial Opioid Agonist [EPC]
Packaging Options(1)
30 POUCH in 1 CARTON (0378-8768-93) / 1 FILM in 1 POUCH (0378-8768-16)