"65219-287-30" National Drug Code (NDC)

Gadobutrol 10 BOTTLE in 1 CARTON (65219-287-30) / 30 mL in 1 BOTTLE (65219-287-10)
(Fresenius Kabi USA, LLC)

NDC Code65219-287-30
Package Description10 BOTTLE in 1 CARTON (65219-287-30) / 30 mL in 1 BOTTLE (65219-287-10)
Product NDC65219-287
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGadobutrol
Non-Proprietary NameGadobutrol
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20231001
Marketing Category NameANDA
Application NumberANDA216081
ManufacturerFresenius Kabi USA, LLC
Substance NameGADOBUTROL
Strength604.72
Strength Unitmg/mL
Pharmacy ClassesGadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]

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