"0378-6117-01" National Drug Code (NDC)

Oxycodone Hydrochloride And Aspirin 100 TABLET in 1 BOTTLE, PLASTIC (0378-6117-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-6117-01
Package Description100 TABLET in 1 BOTTLE, PLASTIC (0378-6117-01)
Product NDC0378-6117
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOxycodone Hydrochloride And Aspirin
Non-Proprietary NameOxycodone Hydrochloride And Aspirin
Dosage FormTABLET
UsageORAL
Start Marketing Date20110502
End Marketing Date20170831
Marketing Category NameANDA
Application NumberANDA091670
ManufacturerMylan Pharmaceuticals Inc.
Substance NameOXYCODONE HYDROCHLORIDE; ASPIRIN
Strength4.8355; 325
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE]
DEA ScheduleCII

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