"68475-011-01" National Drug Code (NDC)

Sodium Phenylbutyrate 1 BOTTLE in 1 CARTON (68475-011-01) / 250 TABLET in 1 BOTTLE
(Navinta LLC)

NDC Code68475-011-01
Package Description1 BOTTLE in 1 CARTON (68475-011-01) / 250 TABLET in 1 BOTTLE
Product NDC68475-011
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSodium Phenylbutyrate
Non-Proprietary NameSodium Phenylbutyrate
Dosage FormTABLET
UsageORAL
Start Marketing Date20260710
Marketing Category NameANDA
Application NumberANDA220418
ManufacturerNavinta LLC
Substance NameSODIUM PHENYLBUTYRATE
Strength500
Strength Unitmg/1
Pharmacy ClassesAmmonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]

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