"0591-3494-05" National Drug Code (NDC)

Oxycodone Hydrochloride And Ibuprofen 500 TABLET in 1 BOTTLE, PLASTIC (0591-3494-05)
(Watson Laboratories, Inc.)

NDC Code0591-3494-05
Package Description500 TABLET in 1 BOTTLE, PLASTIC (0591-3494-05)
Product NDC0591-3494
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOxycodone Hydrochloride And Ibuprofen
Non-Proprietary NameOxycodone Hydrochloride And Ibuprofen
Dosage FormTABLET
UsageORAL
Start Marketing Date20071201
Marketing Category NameANDA
Application NumberANDA078394
ManufacturerWatson Laboratories, Inc.
Substance NameOXYCODONE HYDROCHLORIDE; IBUPROFEN
Strength5; 400
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA ScheduleCII

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