"0603-9013-54" National Drug Code (NDC)

Acetaminophen And Codeine 120 mL in 1 BOTTLE (0603-9013-54)
(Qualitest Pharmaceuticals)

NDC Code0603-9013-54
Package Description120 mL in 1 BOTTLE (0603-9013-54)
Product NDC0603-9013
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAcetaminophen And Codeine
Non-Proprietary NameAcetaminophen And Codeine Phosphate
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20111110
Marketing Category NameANDA
Application NumberANDA091238
ManufacturerQualitest Pharmaceuticals
Substance NameACETAMINOPHEN; CODEINE PHOSPHATE
Strength120; 12
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCV

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