"0480-3777-58" National Drug Code (NDC)

Glycerol Phenylbutyrate 1 BOTTLE in 1 CARTON (0480-3777-58) / 25 mL in 1 BOTTLE
(Teva Pharmaceuticals, Inc.)

NDC Code0480-3777-58
Package Description1 BOTTLE in 1 CARTON (0480-3777-58) / 25 mL in 1 BOTTLE
Product NDC0480-3777
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGlycerol Phenylbutyrate
Non-Proprietary NameGlycerol Phenylbutyrate
Dosage FormLIQUID
UsageORAL
Start Marketing Date20260416
Marketing Category NameANDA
Application NumberANDA218738
ManufacturerTeva Pharmaceuticals, Inc.
Substance NameGLYCEROL PHENYLBUTYRATE
Strength1.1
Strength Unitg/mL
Pharmacy ClassesAmmonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]

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