NDC Code | 0378-7108-01 |
Package Description | 100 TABLET in 1 BOTTLE (0378-7108-01) |
Product NDC | 0378-7108 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Oxycodone And Acetaminophen |
Non-Proprietary Name | Oxycodone Hydrochloride And Acetaminophen |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 20081216 |
Marketing Category Name | ANDA |
Application Number | ANDA090177 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
Strength | 650; 10 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule | CII |