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] |