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Gemcitabine HCl - 57884-4001-1 - (Gemcitabine hydrochloride)

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Drug Information of Gemcitabine HCl

Product NDC: 57884-4001
Proprietary Name: Gemcitabine HCl
Non Proprietary Name: Gemcitabine hydrochloride
Active Ingredient(s): 200    mg/5mL & nbsp;   Gemcitabine hydrochloride
Administration Route(s): INTRAVENOUS
Dosage Form(s): INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Gemcitabine HCl

Product NDC: 57884-4001
Labeler Name: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA202485
Marketing Category: ANDA
Start Marketing Date: 20130508

Package Information of Gemcitabine HCl

Package NDC: 57884-4001-1
Package Description: 1 VIAL in 1 CARTON (57884-4001-1) > 5 mL in 1 VIAL

NDC Information of Gemcitabine HCl

NDC Code 57884-4001-1
Proprietary Name Gemcitabine HCl
Package Description 1 VIAL in 1 CARTON (57884-4001-1) > 5 mL in 1 VIAL
Product NDC 57884-4001
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Gemcitabine hydrochloride
Dosage Form Name INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route Name INTRAVENOUS
Start Marketing Date 20130508
Marketing Category Name ANDA
Labeler Name Jiangsu Hengrui Pharmaceutical Co., Ltd.
Substance Name GEMCITABINE HYDROCHLORIDE
Strength Number 200
Strength Unit mg/5mL
Pharmaceutical Classes Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

Complete Information of Gemcitabine HCl


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