"57884-4001-1" National Drug Code (NDC)

Gemcitabine Hcl 1 VIAL in 1 CARTON (57884-4001-1) > 5 mL in 1 VIAL
(Jiangsu Hengrui Pharmaceutical Co., Ltd.)

NDC Code57884-4001-1
Package Description1 VIAL in 1 CARTON (57884-4001-1) > 5 mL in 1 VIAL
Product NDC57884-4001
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGemcitabine Hcl
Non-Proprietary NameGemcitabine Hydrochloride
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20130508
Marketing Category NameANDA
Application NumberANDA202485
ManufacturerJiangsu Hengrui Pharmaceutical Co., Ltd.
Substance NameGEMCITABINE HYDROCHLORIDE
Strength200
Strength Unitmg/5mL
Pharmacy ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

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