Product NDC: | 0054-8650 |
Proprietary Name: | Roxicet |
Non Proprietary Name: | Oxycodone and Acetaminophen |
Active Ingredient(s): | 325; 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: | 0054-8650 |
Labeler Name: | Roxane Laboratories, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA087003 |
Marketing Category: | ANDA |
Start Marketing Date: | 19870311 |
Package NDC: | 0054-8650-24 |
Package Description: | 4 BLISTER PACK in 1 BOX (0054-8650-24) > 25 TABLET in 1 BLISTER PACK |
NDC Code | 0054-8650-24 |
Proprietary Name | Roxicet |
Package Description | 4 BLISTER PACK in 1 BOX (0054-8650-24) > 25 TABLET in 1 BLISTER PACK |
Product NDC | 0054-8650 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Oxycodone and Acetaminophen |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 19870311 |
Marketing Category Name | ANDA |
Labeler Name | Roxane Laboratories, Inc. |
Substance Name | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
Strength Number | 325; 5 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |