NDC Code | 0378-0924-93 |
Package Description | 30 TABLET in 1 BOTTLE, PLASTIC (0378-0924-93) |
Product NDC | 0378-0924 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Buprenorphine Hydrochloride Sublingual |
Non-Proprietary Name | Buprenorphine Hydrochloride Sublingual |
Dosage Form | TABLET |
Usage | SUBLINGUAL |
Start Marketing Date | 20150306 |
End Marketing Date | 20191031 |
Marketing Category Name | ANDA |
Application Number | ANDA201066 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | BUPRENORPHINE HYDROCHLORIDE |
Strength | 8 |
Strength Unit | mg/1 |
Pharmacy Classes | Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC] |
DEA Schedule | CIII |