| NDC Code | 0054-0189-13 |
|---|
| Package Description | 30 TABLET in 1 BOTTLE (0054-0189-13) |
|---|
| Product NDC | 0054-0189 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate |
|---|
| Non-Proprietary Name | Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate |
|---|
| Dosage Form | TABLET |
|---|
| Usage | SUBLINGUAL |
|---|
| Start Marketing Date | 20140627 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA203326 |
|---|
| Manufacturer | Hikma Pharmaceuticals USA 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 |
|---|