"50419-325-13" National Drug Code (NDC)

Gadavist 2 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE
(Bayer HealthCare Pharmaceuticals Inc.)

NDC Code50419-325-13
Package Description2 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE
Product NDC50419-325
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGadavist
Non-Proprietary NameGadobutrol
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20110314
Marketing Category NameNDA
Application NumberNDA201277
ManufacturerBayer HealthCare Pharmaceuticals Inc.
Substance NameGADOBUTROL
Strength604.72
Strength Unitmg/mL
Pharmacy ClassesGadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]

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