"72245-648-50" National Drug Code (NDC)

Prolate 500 mL in 1 BOTTLE, PLASTIC (72245-648-50)
(Forte Bio-Pharma LLC)

NDC Code72245-648-50
Package Description500 mL in 1 BOTTLE, PLASTIC (72245-648-50)
Product NDC72245-648
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameProlate
Non-Proprietary NameOxycodone Hydrochloride And Acetaminophen
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20200301
Marketing Category NameANDA
Application NumberANDA202142
ManufacturerForte Bio-Pharma LLC
Substance NameACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Strength300; 10
Strength Unitmg/5mL; mg/5mL
Pharmacy ClassesFull Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA ScheduleCII

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