NDC Code | 55700-867-60 |
Package Description | 60 POUCH in 1 BOX (55700-867-60) > 1 FILM, SOLUBLE in 1 POUCH |
Product NDC | 55700-867 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Belbuca |
Non-Proprietary Name | Buprenorphine Hydrochloride |
Dosage Form | FILM, SOLUBLE |
Usage | BUCCAL |
Start Marketing Date | 20200602 |
Marketing Category Name | NDA |
Application Number | NDA207932 |
Manufacturer | Quality Care Products, LLC |
Substance Name | BUPRENORPHINE HYDROCHLORIDE |
Strength | 450 |
Strength Unit | ug/1 |
Pharmacy Classes | Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
DEA Schedule | CIII |