NDC Code | 54123-929-30 |
Package Description | 3 BLISTER PACK in 1 CARTON (54123-929-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Product NDC | 54123-929 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Zubsolv |
Non-Proprietary Name | Buprenorphine Hydrochloride And Naloxone Hydrochloride |
Dosage Form | TABLET, ORALLY DISINTEGRATING |
Usage | SUBLINGUAL |
Start Marketing Date | 20130704 |
Marketing Category Name | NDA |
Application Number | NDA204242 |
Manufacturer | Orexo US, Inc. |
Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
Strength | 2.9; .71 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
DEA Schedule | CIII |