NDC Code | 62756-970-64 |
Package Description | 3 BLISTER PACK in 1 CARTON (62756-970-64) / 10 TABLET in 1 BLISTER PACK |
Product NDC | 62756-970 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Buprenorphine And Naloxone |
Non-Proprietary Name | Buprenorphine And Naloxone |
Dosage Form | TABLET |
Usage | SUBLINGUAL |
Start Marketing Date | 20170718 |
Marketing Category Name | ANDA |
Application Number | ANDA201633 |
Manufacturer | Sun Pharmaceutical Industries, Inc. |
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 |