| 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 |