NDC Code | 0121-2038-30 |
Package Description | 30 TABLET in 1 BOTTLE (0121-2038-30) |
Product NDC | 0121-2038 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Buprenorphine Hydrochloride |
Non-Proprietary Name | Buprenorphine Hydrochloride |
Dosage Form | TABLET |
Usage | SUBLINGUAL |
Start Marketing Date | 20231012 |
Marketing Category Name | ANDA |
Application Number | ANDA090622 |
Manufacturer | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma |
Substance Name | BUPRENORPHINE HYDROCHLORIDE |
Strength | 8 |
Strength Unit | mg/1 |
Pharmacy Classes | Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
DEA Schedule | CIII |