NDC Code | 0378-0923-05 |
Package Description | 500 TABLET in 1 BOTTLE, PLASTIC (0378-0923-05) |
Product NDC | 0378-0923 |
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 |
Marketing Category Name | ANDA |
Application Number | ANDA201066 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | BUPRENORPHINE HYDROCHLORIDE |
Strength | 2 |
Strength Unit | mg/1 |
Pharmacy Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] |
DEA Schedule | CIII |