"68083-502-01" National Drug Code (NDC)

Mitomycin 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-502-01) > 80 mL in 1 VIAL, SINGLE-DOSE
(Gland Pharma Limited)

NDC Code68083-502-01
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (68083-502-01) > 80 mL in 1 VIAL, SINGLE-DOSE
Product NDC68083-502
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMitomycin
Non-Proprietary NameMitomycin
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20221122
Marketing Category NameANDA
Application NumberANDA216648
ManufacturerGland Pharma Limited
Substance NameMITOMYCIN
Strength40
Strength Unitmg/80mL
Pharmacy ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]

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