"69097-314-42" National Drug Code (NDC)

Gemcitabine Hydrochloride 1 VIAL, SINGLE-USE in 1 CARTON (69097-314-42) > 25 mL in 1 VIAL, SINGLE-USE
(Cipla USA Inc.)

NDC Code69097-314-42
Package Description1 VIAL, SINGLE-USE in 1 CARTON (69097-314-42) > 25 mL in 1 VIAL, SINGLE-USE
Product NDC69097-314
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGemcitabine Hydrochloride
Non-Proprietary NameGemcitabine Hydrochloride
Dosage FormINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
UsageINTRAVENOUS
Start Marketing Date20110725
Marketing Category NameANDA
Application NumberANDA078759
ManufacturerCipla USA Inc.
Substance NameGEMCITABINE HYDROCHLORIDE
Strength1
Strength Unitg/25mL
Pharmacy ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

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