| NDC Code | 0781-7249-64 |
| Package Description | 30 POUCH in 1 CARTON (0781-7249-64) > 1 FILM, SOLUBLE in 1 POUCH (0781-7249-06) |
| Product NDC | 0781-7249 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Buprenorphine And Naloxone |
| Non-Proprietary Name | Buprenorphine Hydrochloride, Naloxone Hydrochloride |
| Dosage Form | FILM, SOLUBLE |
| Usage | BUCCAL; SUBLINGUAL |
| Start Marketing Date | 20190219 |
| End Marketing Date | 20210430 |
| Marketing Category Name | NDA AUTHORIZED GENERIC |
| Application Number | NDA022410 |
| Manufacturer | Indivior Inc. |
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
| Strength | 12; 3 |
| 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 |