| NDC Code | 70518-3129-0 |
|---|
| Package Description | 30 TABLET in 1 BLISTER PACK (70518-3129-0) |
|---|
| Product NDC | 70518-3129 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Buprenorphine And Naloxone |
|---|
| Non-Proprietary Name | Buprenorphine And Naloxone |
|---|
| Dosage Form | TABLET |
|---|
| Usage | SUBLINGUAL |
|---|
| Start Marketing Date | 20210617 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA201633 |
|---|
| Manufacturer | REMEDYREPACK INC. |
|---|
| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
|---|
| 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 |
|---|