"45963-612-57" National Drug Code (NDC)

Gemcitabine Hydrochloride 1 VIAL in 1 CARTON (45963-612-57) > 5 mL in 1 VIAL
(Actavis Pharma, Inc.)

NDC Code45963-612-57
Package Description1 VIAL in 1 CARTON (45963-612-57) > 5 mL in 1 VIAL
Product NDC45963-612
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGemcitabine Hydrochloride
Non-Proprietary NameGemcitabine Hydrochloride
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20150202
End Marketing Date20201031
Marketing Category NameANDA
Application NumberANDA079160
ManufacturerActavis Pharma, Inc.
Substance NameGEMCITABINE HYDROCHLORIDE
Strength200
Strength Unitmg/5mL
Pharmacy ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

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