"70710-2066-6" National Drug Code (NDC)

Gadobutrol 10 VIAL, SINGLE-DOSE in 1 CARTON (70710-2066-6) / 15 mL in 1 VIAL, SINGLE-DOSE (70710-2066-1)
(Zydus Pharmaceuticals USA Inc.)

NDC Code70710-2066-6
Package Description10 VIAL, SINGLE-DOSE in 1 CARTON (70710-2066-6) / 15 mL in 1 VIAL, SINGLE-DOSE (70710-2066-1)
Product NDC70710-2066
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGadobutrol
Non-Proprietary NameGadobutrol
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20260714
Marketing Category NameANDA
Application NumberANDA219287
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameGADOBUTROL
Strength604.72
Strength Unitmg/mL
Pharmacy ClassesGadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]

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