NDC Code | 71335-1725-5 |
Package Description | 14 TABLET in 1 BOTTLE, PLASTIC (71335-1725-5) |
Product NDC | 71335-1725 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate |
Non-Proprietary Name | Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate |
Dosage Form | TABLET |
Usage | SUBLINGUAL |
Start Marketing Date | 20171213 |
Marketing Category Name | ANDA |
Application Number | ANDA207000 |
Manufacturer | Bryant Ranch Prepack |
Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
Strength | 8; 2 |
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 |