"70436-214-80" National Drug Code (NDC)

Gadobutrol 1 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-80) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34)
(Slate Run Pharmaceuticals, LLC)

NDC Code70436-214-80
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-80) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34)
Product NDC70436-214
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGadobutrol
Non-Proprietary NameGadobutrol
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20231020
Marketing Category NameANDA
Application NumberANDA217480
ManufacturerSlate Run Pharmaceuticals, LLC
Substance NameGADOBUTROL
Strength604.72
Strength Unitmg/mL
Pharmacy ClassesGadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]

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