"65219-564-20" National Drug Code (NDC)

Mitomycin 1 VIAL in 1 CARTON (65219-564-20) / 10 mL in 1 VIAL
(Fresenius Kabi USA, LLC)

NDC Code65219-564-20
Package Description1 VIAL in 1 CARTON (65219-564-20) / 10 mL in 1 VIAL
Product NDC65219-564
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMitomycin
Non-Proprietary NameMitomycin
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20230115
Marketing Category NameANDA
Application NumberANDA215687
ManufacturerFresenius Kabi USA, LLC
Substance NameMITOMYCIN
Strength5
Strength Unitmg/10mL
Pharmacy ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]

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