"0054-8650-24" National Drug Code (NDC)

Roxicet 4 BLISTER PACK in 1 BOX (0054-8650-24) > 25 TABLET in 1 BLISTER PACK
(Roxane Laboratories, Inc.)

NDC Code0054-8650-24
Package Description4 BLISTER PACK in 1 BOX (0054-8650-24) > 25 TABLET in 1 BLISTER PACK
Product NDC0054-8650
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRoxicet
Non-Proprietary NameOxycodone And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date19870311
Marketing Category NameANDA
Application NumberANDA087003
ManufacturerRoxane Laboratories, Inc.
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Strength5; 325
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII

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