"70518-3492-0" National Drug Code (NDC)

Oxycodone And Acetaminophen 100 POUCH in 1 BOX (70518-3492-0) / 1 TABLET in 1 POUCH (70518-3492-1)
(REMEDYREPACK INC.)

NDC Code70518-3492-0
Package Description100 POUCH in 1 BOX (70518-3492-0) / 1 TABLET in 1 POUCH (70518-3492-1)
Product NDC70518-3492
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOxycodone And Acetaminophen
Non-Proprietary NameOxycodone Hydrochloride And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20220822
Marketing Category NameANDA
Application NumberANDA040545
ManufacturerREMEDYREPACK INC.
Substance NameACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength325; 10
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII

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