"69166-523-04" National Drug Code (NDC)

Obredon 118 mL in 1 BOTTLE (69166-523-04)
(NOVOTEC PHARMA LLC)

NDC Code69166-523-04
Package Description118 mL in 1 BOTTLE (69166-523-04)
Product NDC69166-523
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameObredon
Non-Proprietary NameHydrocodone Bitartrate And Guaifenesin
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20141230
End Marketing Date20180630
Marketing Category NameNDA
Application NumberNDA205474
ManufacturerNOVOTEC PHARMA LLC
Substance NameHYDROCODONE BITARTRATE; GUAIFENESIN
Strength2.5; 200
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII

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