NDC 45963-620

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 Actavis Pharma, Inc.. The primary component is Gemcitabine Hydrochloride.

Product ID45963-620_3474303a-8624-4799-838b-e2ec47556778
NDC45963-620
Product TypeHuman Prescription Drug
Proprietary Namegemcitabine hydrochloride
Generic NameGemcitabine Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-11-03
Marketing End Date2020-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA079160
Labeler NameActavis Pharma, Inc.
Substance NameGEMCITABINE HYDROCHLORIDE
Active Ingredient Strength2 g/50mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN

Packaging

NDC 45963-620-60

1 VIAL in 1 CARTON (45963-620-60) > 50 mL in 1 VIAL
Marketing Start Date2016-11-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-620-60 [45963062060]

gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA079160
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-03
Marketing End Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
GEMCITABINE HYDROCHLORIDE2 g/50mL

OpenFDA Data

SPL SET ID:1eeacf1b-0d89-4cfa-956d-dcb5880b431b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1719005
  • 1719000
  • 1719003
  • UPC Code
  • 0345963612571
  • 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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