"55150-452-01" National Drug Code (NDC)

Mitomycin 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-452-01) / 80 mL in 1 VIAL, SINGLE-DOSE
(Eugia US LLC)

NDC Code55150-452-01
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (55150-452-01) / 80 mL in 1 VIAL, SINGLE-DOSE
Product NDC55150-452
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMitomycin
Non-Proprietary NameMitomycin
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20231030
Marketing Category NameANDA
Application NumberANDA216732
ManufacturerEugia US LLC
Substance NameMITOMYCIN
Strength40
Strength Unitmg/80mL
Pharmacy ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]

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