"39822-2100-2" National Drug Code (NDC)

Dactinomycin 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-2100-2) / 1 mL in 1 VIAL, SINGLE-DOSE (39822-2100-1)
(XGen Pharmaceuticals DJB, Inc.)

NDC Code39822-2100-2
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (39822-2100-2) / 1 mL in 1 VIAL, SINGLE-DOSE (39822-2100-1)
Product NDC39822-2100
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDactinomycin
Non-Proprietary NameDactinomycin
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20190731
Marketing Category NameANDA
Application NumberANDA203999
ManufacturerXGen Pharmaceuticals DJB, Inc.
Substance NameDACTINOMYCIN
Strength.5
Strength Unitmg/mL
Pharmacy ClassesActinomycin [EPC], Nucleic Acid Synthesis Inhibitors [MoA], Protein Synthesis Inhibitors [MoA]

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