NDC 65219-086

Gadoterate Meglumine

Gadoterate Meglumine

Gadoterate Meglumine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Gadoterate Meglumine.

Product ID65219-086_afd3cf46-3d9c-4d0e-a02a-42cf846ba1e7
Product TypeHuman Prescription Drug
Proprietary NameGadoterate Meglumine
Generic NameGadoterate Meglumine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-06-20
Marketing CategoryANDA /
Application NumberANDA215304
Labeler NameFresenius Kabi USA, LLC
Active Ingredient Strength377 mg/mL
Pharm ClassesGadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31


NDC 65219-086-20

10 CARTON in 1 BOX (65219-086-20) > 1 VIAL in 1 CARTON (65219-086-01) > 20 mL in 1 VIAL
Marketing Start Date2022-06-20
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Gadoterate Meglumine" or generic name "Gadoterate Meglumine"

NDCBrand NameGeneric Name
65219-080Gadoterate Megluminegadoterate meglumine
65219-082Gadoterate Megluminegadoterate meglumine
65219-084Gadoterate Megluminegadoterate meglumine
65219-086Gadoterate Megluminegadoterate meglumine
0407-2943CLARISCANgadoterate meglumine
67684-2000DOTAREMgadoterate meglumine
67684-2001DOTAREMgadoterate meglumine
67684-3001DOTAREMgadoterate meglumine

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