"0054-2795-25" National Drug Code (NDC)

Oxycodone Hydrochloride And Acetaminophen 100 CAPSULE in 1 BOTTLE, PLASTIC (0054-2795-25)
(Roxane Laboratories, Inc)

NDC Code0054-2795-25
Package Description100 CAPSULE in 1 BOTTLE, PLASTIC (0054-2795-25)
Product NDC0054-2795
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOxycodone Hydrochloride And Acetaminophen
Non-Proprietary NameOxycodone Hydrochloride And Acetaminophen
Dosage FormCAPSULE
UsageORAL
Start Marketing Date19950703
Marketing Category NameANDA
Application NumberANDA040061
ManufacturerRoxane Laboratories, Inc
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Strength5; 500
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII

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