| NDC Code | 0378-0924-05 |
|---|
| Package Description | 500 TABLET in 1 BOTTLE, PLASTIC (0378-0924-05) |
|---|
| Product NDC | 0378-0924 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Buprenorphine Hydrochloride Sublingual |
|---|
| Non-Proprietary Name | Buprenorphine Hydrochloride Sublingual |
|---|
| Dosage Form | TABLET |
|---|
| Usage | SUBLINGUAL |
|---|
| Start Marketing Date | 20150306 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA201066 |
|---|
| Manufacturer | Mylan Pharmaceuticals Inc. |
|---|
| Substance Name | BUPRENORPHINE HYDROCHLORIDE |
|---|
| Strength | 8 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] |
|---|
| DEA Schedule | CIII |
|---|