"43386-492-01" National Drug Code (NDC)

Oxycodone And Acetaminophen 100 TABLET in 1 BOTTLE (43386-492-01)
(Lupin Pharmaceuticals,Inc.)

NDC Code43386-492-01
Package Description100 TABLET in 1 BOTTLE (43386-492-01)
Product NDC43386-492
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOxycodone And Acetaminophen
Non-Proprietary NameOxycodone And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20170224
Marketing Category NameANDA
Application NumberANDA204407
ManufacturerLupin Pharmaceuticals,Inc.
Substance NameACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength325; 7.5
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII

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