"66658-105-60" National Drug Code (NDC)

Orfadin 1 BOTTLE, PLASTIC in 1 CARTON (66658-105-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC
(SWEDISH ORPHAN BIOVITRUM AB (PUBL))

NDC Code66658-105-60
Package Description1 BOTTLE, PLASTIC in 1 CARTON (66658-105-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC
Product NDC66658-105
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOrfadin
Non-Proprietary NameNitisinone
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20160701
Marketing Category NameNDA
Application NumberNDA021232
ManufacturerSWEDISH ORPHAN BIOVITRUM AB (PUBL)
Substance NameNITISINONE
Strength5
Strength Unitmg/1
Pharmacy Classes4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2E1 Inducers [MoA], Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]

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