| Product NDC: | 0054-2795 |
| Proprietary Name: | Oxycodone Hydrochloride and Acetaminophen |
| Non Proprietary Name: | Oxycodone Hydrochloride and Acetaminophen |
| Active Ingredient(s): | 500; 5 mg/1; mg/1 & nbsp; Oxycodone Hydrochloride and Acetaminophen |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0054-2795 |
| Labeler Name: | Roxane Laboratories, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040061 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19950703 |
| Package NDC: | 0054-2795-25 |
| Package Description: | 100 CAPSULE in 1 BOTTLE, PLASTIC (0054-2795-25) |
| NDC Code | 0054-2795-25 |
| Proprietary Name | Oxycodone Hydrochloride and Acetaminophen |
| Package Description | 100 CAPSULE in 1 BOTTLE, PLASTIC (0054-2795-25) |
| Product NDC | 0054-2795 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Oxycodone Hydrochloride and Acetaminophen |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 19950703 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc |
| Substance Name | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
| Strength Number | 500; 5 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |