"68475-807-01" National Drug Code (NDC)

Glycerol Phenylbutyrate 1 BOTTLE in 1 CARTON (68475-807-01) / 25 mL in 1 BOTTLE
(Navinta LLC)

NDC Code68475-807-01
Package Description1 BOTTLE in 1 CARTON (68475-807-01) / 25 mL in 1 BOTTLE
Product NDC68475-807
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGlycerol Phenylbutyrate
Non-Proprietary NameGlycerol Phenylbutyrate
Dosage FormLIQUID
UsageORAL
Start Marketing Date20260711
Marketing Category NameANDA
Application NumberANDA220568
ManufacturerNavinta LLC
Substance NameGLYCEROL PHENYLBUTYRATE
Strength1.1
Strength Unitg/mL
Pharmacy ClassesAmmonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]

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