"69101-620-01" National Drug Code (NDC)

Hydrocodone Bitartrate And Guaifenesin 118 mL in 1 BOTTLE (69101-620-01)
(Burke Therapeutics)

NDC Code69101-620-01
Package Description118 mL in 1 BOTTLE (69101-620-01)
Product NDC69101-620
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Guaifenesin
Non-Proprietary NameHydrocodone Bitartrate And Guaifenesin
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20181002
Marketing Category NameNDA
Application NumberNDA205474
ManufacturerBurke Therapeutics
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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