"67684-3001-3" National Drug Code (NDC)

Dotarem 10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-3) / 20 mL in 1 SYRINGE, PLASTIC
(Guerbet LLC)

NDC Code67684-3001-3
Package Description10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-3) / 20 mL in 1 SYRINGE, PLASTIC
Product NDC67684-3001
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDotarem
Non-Proprietary NameGadoterate Meglumine
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20190918
Marketing Category NameNDA
Application NumberNDA204781
ManufacturerGuerbet LLC
Substance NameGADOTERATE MEGLUMINE
Strength376.9
Strength Unitmg/mL
Pharmacy ClassesGadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]

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