"65219-082-10" National Drug Code (NDC)

Gadoterate Meglumine 10 CARTON in 1 BOX (65219-082-10) / 1 VIAL in 1 CARTON (65219-082-01) / 10 mL in 1 VIAL
(Fresenius Kabi USA, LLC)

NDC Code65219-082-10
Package Description10 CARTON in 1 BOX (65219-082-10) / 1 VIAL in 1 CARTON (65219-082-01) / 10 mL in 1 VIAL
Product NDC65219-082
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGadoterate Meglumine
Non-Proprietary NameGadoterate Meglumine
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20220620
Marketing Category NameANDA
Application NumberANDA215304
ManufacturerFresenius Kabi USA, LLC
Substance NameGADOTERATE MEGLUMINE
Strength376.9
Strength Unitmg/mL
Pharmacy ClassesGadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]

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