NDC Code | 59385-016-30 |
Package Description | 30 POUCH in 1 BOX (59385-016-30) > 1 FILM in 1 POUCH (59385-016-01) |
Product NDC | 59385-016 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Bunavail |
Non-Proprietary Name | Buprenorphine And Naloxone |
Dosage Form | FILM |
Usage | BUCCAL |
Start Marketing Date | 20140930 |
End Marketing Date | 20210731 |
Marketing Category Name | NDA |
Application Number | NDA205637 |
Manufacturer | BioDelivery Sciences International, Inc. |
Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
Strength | 6.3; 1 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
DEA Schedule | CIII |