"65219-568-00" National Drug Code (NDC)

Mitomycin 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-568-00) / 80 mL in 1 VIAL, SINGLE-DOSE
(Fresenius Kabi USA, LLC)

NDC Code65219-568-00
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (65219-568-00) / 80 mL in 1 VIAL, SINGLE-DOSE
Product NDC65219-568
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMitomycin
Non-Proprietary NameMitomycin
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20230115
Marketing Category NameANDA
Application NumberANDA216648
ManufacturerFresenius Kabi USA, LLC
Substance NameMITOMYCIN
Strength40
Strength Unitmg/80mL
Pharmacy ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]

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