"65219-824-01" National Drug Code (NDC)

Otulfi 1 SYRINGE in 1 CARTON (65219-824-01) / .5 mL in 1 SYRINGE
(Fresenius Kabi USA, LLC)

NDC Code65219-824-01
Package Description1 SYRINGE in 1 CARTON (65219-824-01) / .5 mL in 1 SYRINGE
Product NDC65219-824
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameOtulfi
Non-Proprietary NameUstekinumab-aauz
Dosage FormINJECTION, SOLUTION
UsageSUBCUTANEOUS
Start Marketing Date20240222
Marketing Category NameBLA
Application NumberBLA761379
ManufacturerFresenius Kabi USA, LLC
Substance NameUSTEKINUMAB
Strength45
Strength Unitmg/.5mL
Pharmacy ClassesInterleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]

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