NDC 68083-149

gemcitabine hydrochloride

Gemcitabine Hydrochloride

gemcitabine hydrochloride is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Gemcitabine Hydrochloride.

Product ID68083-149_5670120a-b079-4147-9450-91b0fa9e75cc
NDC68083-149
Product TypeHuman Prescription Drug
Proprietary Namegemcitabine hydrochloride
Generic NameGemcitabine Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA204520
Labeler NameGland Pharma Limited
Substance NameGEMCITABINE HYDROCHLORIDE
Active Ingredient Strength1 g/25mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-149-01

1 VIAL in 1 CARTON (68083-149-01) > 25 mL in 1 VIAL
Marketing Start Date2016-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-149-01 [68083014901]

gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204520
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-02-01

Drug Details

Active Ingredients

IngredientStrength
GEMCITABINE HYDROCHLORIDE1 g/25mL

OpenFDA Data

SPL SET ID:9f8fe5ba-943f-4f0a-9618-6083101faa28
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1719000
  • 1719003
  • Pharmacological Class

    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Nucleoside Metabolic Inhibitor [EPC]

    NDC Crossover Matching brand name "gemcitabine hydrochloride" or generic name "Gemcitabine Hydrochloride"

    NDCBrand NameGeneric Name
    16729-092GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
    16729-117GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
    16729-118GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
    23155-213Gemcitabine hydrochlorideGemcitabine hydrochloride
    23155-214Gemcitabine hydrochlorideGemcitabine hydrochloride
    23155-483Gemcitabine hydrochlorideGemcitabine hydrochloride
    23155-484Gemcitabine hydrochlorideGemcitabine hydrochloride
    23155-528Gemcitabine hydrochlorideGemcitabine hydrochloride
    23155-529Gemcitabine hydrochlorideGemcitabine hydrochloride
    45963-612gemcitabine hydrochloridegemcitabine hydrochloride
    45963-619gemcitabine hydrochloridegemcitabine hydrochloride
    45963-620gemcitabine hydrochloridegemcitabine hydrochloride
    68001-282Gemcitabine HydrochlorideGemcitabine Hydrochloride
    68083-149gemcitabine hydrochloridegemcitabine hydrochloride
    68083-148gemcitabine hydrochloridegemcitabine hydrochloride
    69097-314GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
    69097-313GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
    67457-462GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
    67457-463GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
    67457-464GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
    16714-909GEMCITABINEGEMCITABINE HYDROCHLORIDE
    16714-930GEMCITABINEGEMCITABINE HYDROCHLORIDE
    25021-234gemcitabinegemcitabine hydrochloride
    25021-235gemcitabinegemcitabine hydrochloride
    0002-7501GemzarGemcitabine hydrochloride
    0002-7502GemzarGemcitabine hydrochloride

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