| Product NDC: | 0378-7108 |
| Proprietary Name: | Oxycodone and Acetaminophen |
| Non Proprietary Name: | Oxycodone hydrochloride and Acetaminophen |
| Active Ingredient(s): | 650; 10 mg/1; mg/1 & nbsp; Oxycodone hydrochloride and Acetaminophen |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0378-7108 |
| Labeler Name: | Mylan Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA090177 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20081216 |
| Package NDC: | 0378-7108-01 |
| Package Description: | 100 TABLET in 1 BOTTLE (0378-7108-01) |
| NDC Code | 0378-7108-01 |
| Proprietary Name | Oxycodone and Acetaminophen |
| Package Description | 100 TABLET in 1 BOTTLE (0378-7108-01) |
| Product NDC | 0378-7108 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Oxycodone hydrochloride and Acetaminophen |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20081216 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
| Strength Number | 650; 10 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |