"65219-281-10" National Drug Code (NDC)

Gadobutrol 2 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08)
(Fresenius Kabi USA, LLC)

NDC Code65219-281-10
Package Description2 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08)
Product NDC65219-281
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGadobutrol
Non-Proprietary NameGadobutrol
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20230414
Marketing Category NameANDA
Application NumberANDA215061
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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