NDC 0002-7501

Gemzar

Gemcitabine Hydrochloride

Gemzar is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Gemcitabine Hydrochloride.

Product ID0002-7501_24fd471c-d8b6-4e92-8c5e-4907960359c1
NDC0002-7501
Product TypeHuman Prescription Drug
Proprietary NameGemzar
Generic NameGemcitabine Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1996-05-15
Marketing CategoryNDA / NDA
Application NumberNDA020509
Labeler NameEli Lilly and Company
Substance NameGEMCITABINE HYDROCHLORIDE
Active Ingredient Strength200 mg/5mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0002-7501-01

5 mL in 1 VIAL (0002-7501-01)
Marketing Start Date1996-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0002-7501-01 [00002750101]

Gemzar INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA020509
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-05-22
Marketing End Date2020-05-31

Drug Details

Active Ingredients

IngredientStrength
GEMCITABINE HYDROCHLORIDE200 mg/5mL

OpenFDA Data

SPL SET ID:9dc35c59-f4f3-43b4-8251-0cf5c06cdc80
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1719013
  • 1719000
  • 1719003
  • 1719015

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Gemzar" or generic name "Gemcitabine Hydrochloride"

    NDCBrand NameGeneric Name
    0002-7501GemzarGemcitabine hydrochloride
    0002-7502GemzarGemcitabine hydrochloride
    16714-909GEMCITABINEGEMCITABINE HYDROCHLORIDE
    16714-930GEMCITABINEGEMCITABINE HYDROCHLORIDE
    25021-234gemcitabinegemcitabine hydrochloride
    25021-235gemcitabinegemcitabine hydrochloride
    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

    Trademark Results [Gemzar]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GEMZAR
    GEMZAR
    98017463 not registered Live/Pending
    Ingenus Pharmaceuticals, LLC
    2023-05-29
    GEMZAR
    GEMZAR
    74084301 1678979 Live/Registered
    Eli Lilly and Company
    1990-08-02
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