"65219-383-10" National Drug Code (NDC)

Iodixanol 10 BOTTLE, PLASTIC in 1 BOX (65219-383-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-383-04)
(FRESENIUS KABI USA, LLC)

NDC Code65219-383-10
Package Description10 BOTTLE, PLASTIC in 1 BOX (65219-383-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-383-04)
Product NDC65219-383
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIodixanol
Non-Proprietary NameIodixanol
Dosage FormINJECTION, SOLUTION
UsageINTRAVASCULAR
Start Marketing Date20220621
Marketing Category NameANDA
Application NumberANDA214271
ManufacturerFRESENIUS KABI USA, LLC
Substance NameIODIXANOL
Strength320
Strength Unitmg/mL
Pharmacy ClassesRadiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]

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