| Product NDC: | 59702-681 | 
| Proprietary Name: | Primlev | 
| Non Proprietary Name: | oxycodone and acetaminophen | 
| Active Ingredient(s): | 300; 5 mg/1; mg/1 & nbsp; oxycodone and acetaminophen | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 59702-681 | 
| Labeler Name: | Atley Pharmaceuticals | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA040608 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20091123 | 
| Package NDC: | 59702-681-01 | 
| Package Description: | 100 TABLET in 1 BOTTLE (59702-681-01) | 
| NDC Code | 59702-681-01 | 
| Proprietary Name | Primlev | 
| Package Description | 100 TABLET in 1 BOTTLE (59702-681-01) | 
| Product NDC | 59702-681 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | oxycodone and acetaminophen | 
| Dosage Form Name | TABLET | 
| Route Name | ORAL | 
| Start Marketing Date | 20091123 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Atley Pharmaceuticals | 
| Substance Name | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 
| Strength Number | 300; 5 | 
| Strength Unit | mg/1; mg/1 | 
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |