"70436-212-54" National Drug Code (NDC)

Gadobutrol 20 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-54) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32)
(Slate Run Pharmaceuticals, LLC)

NDC Code70436-212-54
Package Description20 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-54) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32)
Product NDC70436-212
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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