"0121-0827-04" National Drug Code (NDC)

Oxycodone Hydrochloride 118 mL in 1 BOTTLE (0121-0827-04)
(PAI Holdings, LLC dba PAI Pharma)

NDC Code0121-0827-04
Package Description118 mL in 1 BOTTLE (0121-0827-04)
Product NDC0121-0827
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOxycodone Hydrochloride
Non-Proprietary NameOxycodone Hydrochloride
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20190408
Marketing Category NameANDA
Application NumberANDA206914
ManufacturerPAI Holdings, LLC dba PAI Pharma
Substance NameOXYCODONE HYDROCHLORIDE
Strength5
Strength Unitmg/5mL
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII

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