"16590-878-40" National Drug Code (NDC)

Reprexain 40 TABLET, FILM COATED in 1 BOTTLE (16590-878-40)
(Stat Rx USA)

NDC Code16590-878-40
Package Description40 TABLET, FILM COATED in 1 BOTTLE (16590-878-40)
Product NDC16590-878
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameReprexain
Non-Proprietary NameHydrocodone Bitartrate, Ibuprofen
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20081216
Marketing Category NameANDA
Application NumberANDA076642
ManufacturerStat Rx USA
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Strength5; 200
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA ScheduleCIII

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