Product NDC: | 50458-526 |
Proprietary Name: | TYLOX |
Non Proprietary Name: | acetaminophen and oxycodone hydrochloride |
Active Ingredient(s): | 500; 5 mg/1; mg/1 & nbsp; acetaminophen and oxycodone hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50458-526 |
Labeler Name: | Ortho-McNeil-Janssen Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA088790 |
Marketing Category: | ANDA |
Start Marketing Date: | 19841212 |
Package NDC: | 50458-526-60 |
Package Description: | 100 CAPSULE in 1 BOTTLE (50458-526-60) |
NDC Code | 50458-526-60 |
Proprietary Name | TYLOX |
Package Description | 100 CAPSULE in 1 BOTTLE (50458-526-60) |
Product NDC | 50458-526 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | acetaminophen and oxycodone hydrochloride |
Dosage Form Name | CAPSULE |
Route Name | ORAL |
Start Marketing Date | 19841212 |
Marketing Category Name | ANDA |
Labeler Name | Ortho-McNeil-Janssen Pharmaceuticals, 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] |