"50458-526-79" National Drug Code (NDC)

Tylox 100 CAPSULE in 1 BOX, UNIT-DOSE (50458-526-79)
(Ortho-McNeil-Janssen Pharmaceuticals, Inc.)

NDC Code50458-526-79
Package Description100 CAPSULE in 1 BOX, UNIT-DOSE (50458-526-79)
Product NDC50458-526
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTylox
Non-Proprietary NameAcetaminophen And Oxycodone Hydrochloride
Dosage FormCAPSULE
UsageORAL
Start Marketing Date19841212
Marketing Category NameANDA
Application NumberANDA088790
ManufacturerOrtho-McNeil-Janssen Pharmaceuticals, Inc.
Substance NameACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength500; 5
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII

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