"50991-578-01" National Drug Code (NDC)

Ibudone 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50991-578-01)
(Poly Pharmaceuticals)

NDC Code50991-578-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50991-578-01)
Product NDC50991-578
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIbudone
Non-Proprietary NameHydrocodone Bitartrate And Ibuprofen
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20061106
Marketing Category NameANDA
Application NumberANDA077727
ManufacturerPoly Pharmaceuticals
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 ScheduleCII

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