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Gemcitabine Hydrochloride - 16729-092-03 - (Gemcitabine Hydrochloride)

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Drug Information of Gemcitabine Hydrochloride

Product NDC: 16729-092
Proprietary Name: Gemcitabine Hydrochloride
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 Hydrochloride

Product NDC: 16729-092
Labeler Name: Accord Healthcare, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA091594
Marketing Category: ANDA
Start Marketing Date: 20110725

Package Information of Gemcitabine Hydrochloride

Package NDC: 16729-092-03
Package Description: 1 VIAL in 1 CARTON (16729-092-03) > 5 mL in 1 VIAL

NDC Information of Gemcitabine Hydrochloride

NDC Code 16729-092-03
Proprietary Name Gemcitabine Hydrochloride
Package Description 1 VIAL in 1 CARTON (16729-092-03) > 5 mL in 1 VIAL
Product NDC 16729-092
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 20110725
Marketing Category Name ANDA
Labeler Name Accord Healthcare, Inc.
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 Hydrochloride


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