"68083-528-01" National Drug Code (NDC)

Decitabine 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-528-01) > 10 mL in 1 VIAL, SINGLE-DOSE
(Gland Pharma Limited)

NDC Code68083-528-01
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (68083-528-01) > 10 mL in 1 VIAL, SINGLE-DOSE
Product NDC68083-528
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDecitabine
Non-Proprietary NameDecitabine
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20201123
Marketing Category NameANDA
Application NumberANDA205539
ManufacturerGland Pharma Limited
Substance NameDECITABINE
Strength50
Strength Unitmg/10mL
Pharmacy ClassesNucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]

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