"0121-1049-25" National Drug Code (NDC)

Glycerol Phenylbutyrate 1 BOTTLE in 1 CARTON (0121-1049-25) / 25 mL in 1 BOTTLE
(PAI Holdings, LLC dba PAI Pharma)

NDC Code0121-1049-25
Package Description1 BOTTLE in 1 CARTON (0121-1049-25) / 25 mL in 1 BOTTLE
Product NDC0121-1049
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGlycerol Phenylbutyrate
Non-Proprietary NameGlycerol Phenylbutyrate
Dosage FormLIQUID
UsageORAL
Start Marketing Date20261012
Marketing Category NameANDA
Application NumberANDA220579
ManufacturerPAI Holdings, LLC dba PAI Pharma
Substance NameGLYCEROL PHENYLBUTYRATE
Strength1.1
Strength Unitg/mL
Pharmacy ClassesAmmonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]

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