"0054-0522-44" National Drug Code (NDC)

Oxycodone Hydrochloride 30 mL in 1 BOTTLE (0054-0522-44)
(Roxane Laboratories, Inc.)

NDC Code0054-0522-44
Package Description30 mL in 1 BOTTLE (0054-0522-44)
Product NDC0054-0522
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOxycodone Hydrochloride
Non-Proprietary NameOxycodone Hydrochloride
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20130716
Marketing Category NameANDA
Application NumberANDA203208
ManufacturerRoxane Laboratories, Inc.
Substance NameOXYCODONE HYDROCHLORIDE
Strength100
Strength Unitmg/5mL
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII

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