"70436-123-31" National Drug Code (NDC)

Gadoterate Meglumine 10 VIAL in 1 CARTON (70436-123-31) / 5 mL in 1 VIAL
(Slate Run Pharmaceuticals, LLC)

NDC Code70436-123-31
Package Description10 VIAL in 1 CARTON (70436-123-31) / 5 mL in 1 VIAL
Product NDC70436-123
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGadoterate Meglumine
Non-Proprietary NameGadoterate Meglumine
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20240628
Marketing Category NameANDA
Application NumberANDA218073
ManufacturerSlate Run Pharmaceuticals, LLC
Substance NameGADOTERATE MEGLUMINE
Strength376.9
Strength Unitmg/mL
Pharmacy ClassesGadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]

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