TYLOX - 50458-526-79 - (acetaminophen and oxycodone hydrochloride)

Alphabetical Index


Drug Information of TYLOX

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)

Labeler Information of TYLOX

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 Information of TYLOX

Package NDC: 50458-526-79
Package Description: 100 CAPSULE in 1 BOX, UNIT-DOSE (50458-526-79)

NDC Information of TYLOX

NDC Code 50458-526-79
Proprietary Name TYLOX
Package Description 100 CAPSULE in 1 BOX, UNIT-DOSE (50458-526-79)
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]

Complete Information of TYLOX


General Information