"0054-4650-25" National Drug Code (NDC)

Roxicet 100 TABLET in 1 BOTTLE, PLASTIC (0054-4650-25)
(Roxane Laboratories, Inc.)

NDC Code0054-4650-25
Package Description100 TABLET in 1 BOTTLE, PLASTIC (0054-4650-25)
Product NDC0054-4650
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRoxicet
Non-Proprietary NameOxycodone And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date19910201
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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