"50458-513-80" National Drug Code (NDC)

Tylenol With Codeine 1000 TABLET in 1 BOTTLE (50458-513-80)
(Janssen Pharmaceuticals, Inc.)

NDC Code50458-513-80
Package Description1000 TABLET in 1 BOTTLE (50458-513-80)
Product NDC50458-513
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTylenol With Codeine
Non-Proprietary NameAcetaminophen And Codeine Phosphate
Dosage FormTABLET
UsageORAL
Start Marketing Date19770817
Marketing Category NameANDA
Application NumberANDA085055
ManufacturerJanssen Pharmaceuticals, Inc.
Substance NameACETAMINOPHEN; CODEINE PHOSPHATE
Strength300; 30
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIII

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