NDC Code | 42858-602-03 |
Package Description | 30 TABLET in 1 BOTTLE, PLASTIC (42858-602-03) |
Product NDC | 42858-602 |
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 | 20200413 |
Marketing Category Name | ANDA |
Application Number | ANDA205601 |
Manufacturer | Rhodes Pharmaceuticals L.P. |
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 |