"68308-841-01" National Drug Code (NDC)

Oxycodone And Acetaminophen 100 TABLET in 1 BOTTLE, PLASTIC (68308-841-01)
(Mayne Pharma Inc.)

NDC Code68308-841-01
Package Description100 TABLET in 1 BOTTLE, PLASTIC (68308-841-01)
Product NDC68308-841
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOxycodone And Acetaminophen
Non-Proprietary NameOxycodone Hydrochloride And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20081216
Marketing Category NameANDA
Application NumberANDA090177
ManufacturerMayne Pharma Inc.
Substance NameOXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Strength5; 325
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII

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