NDC 23155-484

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 Heritage Pharmaceuticals Inc.. The primary component is Gemcitabine Hydrochloride.

Product ID23155-484_7e85d62c-003c-4dc5-9ea0-804d2f425546
NDC23155-484
Product TypeHuman Prescription Drug
Proprietary NameGemcitabine hydrochloride
Generic NameGemcitabine Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2012-10-22
Marketing CategoryANDA / ANDA
Application NumberANDA202063
Labeler NameHeritage Pharmaceuticals Inc.
Substance NameGEMCITABINE HYDROCHLORIDE
Active Ingredient Strength1 g/25mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 23155-484-31

1 VIAL, GLASS in 1 CARTON (23155-484-31) > 25 mL in 1 VIAL, GLASS
Marketing Start Date2012-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 23155-484-31 [23155048431]

Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA202063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-10-22
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
GEMCITABINE HYDROCHLORIDE1 g/25mL

OpenFDA Data

SPL SET ID:81399444-3a4f-4a22-ab1d-b99896f3a211
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1719000
  • 1719003
  • UPC Code
  • 0323155483314
  • 0323155484311
  • 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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