NDC Code | 12496-1208-3 |
Package Description | 30 POUCH in 1 CARTON (12496-1208-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1208-1) |
Product NDC | 12496-1208 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Suboxone |
Non-Proprietary Name | Buprenorphine Hydrochloride, Naloxone Hydrochloride |
Dosage Form | FILM, SOLUBLE |
Usage | BUCCAL; SUBLINGUAL |
Start Marketing Date | 20100913 |
Marketing Category Name | NDA |
Application Number | NDA022410 |
Manufacturer | INDIVIOR INC. |
Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
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 |