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GEMCITABINE HYDROCHLORIDE - 63323-125-50 - (GEMCITABINE)

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Drug Information of GEMCITABINE HYDROCHLORIDE

Product NDC: 63323-125
Proprietary Name: GEMCITABINE HYDROCHLORIDE
Non Proprietary Name: GEMCITABINE
Active Ingredient(s): 1    g/25mL & nbsp;   GEMCITABINE
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: 63323-125
Labeler Name: APP Pharmaceuticals, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090799
Marketing Category: ANDA
Start Marketing Date: 20110726

Package Information of GEMCITABINE HYDROCHLORIDE

Package NDC: 63323-125-50
Package Description: 25 mL in 1 VIAL (63323-125-50)

NDC Information of GEMCITABINE HYDROCHLORIDE

NDC Code 63323-125-50
Proprietary Name GEMCITABINE HYDROCHLORIDE
Package Description 25 mL in 1 VIAL (63323-125-50)
Product NDC 63323-125
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name GEMCITABINE
Dosage Form Name INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route Name INTRAVENOUS
Start Marketing Date 20110726
Marketing Category Name ANDA
Labeler Name APP Pharmaceuticals, LLC
Substance Name GEMCITABINE HYDROCHLORIDE
Strength Number 1
Strength Unit g/25mL
Pharmaceutical Classes Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

Complete Information of GEMCITABINE HYDROCHLORIDE


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