"72245-683-10" National Drug Code (NDC)

Prolate 100 TABLET in 1 BOTTLE, PLASTIC (72245-683-10)
(Forte Bio-Pharma LLC)

NDC Code72245-683-10
Package Description100 TABLET in 1 BOTTLE, PLASTIC (72245-683-10)
Product NDC72245-683
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameProlate
Non-Proprietary NameOxycodone And Acetaminophen
Dosage FormTABLET
UsageORAL
Start Marketing Date20200217
Marketing Category NameANDA
Application NumberANDA040608
ManufacturerForte Bio-Pharma LLC
Substance NameACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength300; 10
Strength Unitmg/1; mg/1
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII

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