"0603-3897-32" National Drug Code (NDC)

Hydrocodone Bitartrate And Ibuprofen 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3897-32)
(Qualitest Pharmaceuticals)

NDC Code0603-3897-32
Package Description1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3897-32)
Product NDC0603-3897
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Ibuprofen
Non-Proprietary NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20061106
Marketing Category NameANDA
Application NumberANDA077723
ManufacturerQualitest Pharmaceuticals
Substance NameHYDROCODONE BITARTRATE; IBUPROFEN
Strength7.5; 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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