"63323-125-94" National Drug Code (NDC)

Gemcitabine 1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-94) > 25 mL in 1 VIAL, SINGLE-DOSE
(Fresenius Kabi USA, LLC)

NDC Code63323-125-94
Package Description1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-94) > 25 mL in 1 VIAL, SINGLE-DOSE
Product NDC63323-125
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGemcitabine
Non-Proprietary NameGemcitabine
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20110726
Marketing Category NameANDA
Application NumberANDA090799
ManufacturerFresenius Kabi USA, LLC
Substance NameGEMCITABINE HYDROCHLORIDE
Strength1
Strength Unitg/25mL
Pharmacy ClassesNucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]

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