NDC 23155-214

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 ID23155-214_8f3aa8bb-a2aa-4029-8e40-23b69905012c
NDC23155-214
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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 23155-214-31

1 VIAL, GLASS in 1 CARTON (23155-214-31) > 25 mL in 1 VIAL, GLASS
Marketing Start Date2012-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 23155-214-31 [23155021431]

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

Drug Details

Active Ingredients

IngredientStrength
GEMCITABINE HYDROCHLORIDE1 g/25mL

OpenFDA Data

SPL SET ID:49f9e774-52f9-40af-aecf-217c11e243ce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1719000
  • 1719003
  • UPC Code
  • 0323155213317
  • 0323155214314
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.