"64850-623-01" National Drug Code (NDC)

Oxycodone Hydrochloride And Acetaminophen 100 TABLET in 1 BOTTLE (64850-623-01)
(Elite Laboratories, Inc.)

NDC Code64850-623-01
Package Description100 TABLET in 1 BOTTLE (64850-623-01)
Product NDC64850-623
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOxycodone Hydrochloride And Acetaminophen
Non-Proprietary NameOxycodone Hydrochloride And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20171204
Marketing Category NameANDA
Application NumberANDA209385
ManufacturerElite Laboratories, 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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