"68083-483-01" National Drug Code (NDC)

Mitomycin 1 VIAL in 1 CARTON (68083-483-01) > 10 mL in 1 VIAL
(Gland Pharma Limited)

NDC Code68083-483-01
Package Description1 VIAL in 1 CARTON (68083-483-01) > 10 mL in 1 VIAL
Product NDC68083-483
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMitomycin
Non-Proprietary NameMitomycin
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20211020
Marketing Category NameANDA
Application NumberANDA215687
ManufacturerGland Pharma Limited
Substance NameMITOMYCIN
Strength5
Strength Unitmg/10mL
Pharmacy ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]

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