| NDC Code | 0121-2036-30 |
|---|
| Package Description | 30 TABLET in 1 BOTTLE, PLASTIC (0121-2036-30) |
|---|
| Product NDC | 0121-2036 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Buprenorphine And Naloxone |
|---|
| Non-Proprietary Name | Buprenorphine Hydrochloride And Naloxone Hydrochloride |
|---|
| Dosage Form | TABLET |
|---|
| Usage | SUBLINGUAL |
|---|
| Start Marketing Date | 20230905 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA204431 |
|---|
| Manufacturer | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma |
|---|
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
|---|
| 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 |
|---|