NDC 68001-282

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 Bluepoint Laboratories. The primary component is Gemcitabine Hydrochloride.

Product ID68001-282_338134f6-dbe3-215c-e054-00144ff88e88
NDC68001-282
Product TypeHuman Prescription Drug
Proprietary NameGemcitabine Hydrochloride
Generic NameGemcitabine Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2011-07-25
Marketing CategoryANDA / ANDA
Application NumberANDA091594
Labeler NameBluePoint Laboratories
Substance NameGEMCITABINE HYDROCHLORIDE
Active Ingredient Strength38 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68001-282-25

1 VIAL in 1 CARTON (68001-282-25) > 5 mL in 1 VIAL (68001-282-22)
Marketing Start Date2016-05-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68001-282-25 [68001028225]

Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091594
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-23

NDC 68001-282-23 [68001028223]

Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091594
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-25

NDC 68001-282-27 [68001028227]

Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091594
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-23

NDC 68001-282-22 [68001028222]

Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091594
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-25

NDC 68001-282-26 [68001028226]

Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091594
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-23

NDC 68001-282-24 [68001028224]

Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091594
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-25

Drug Details

Active Ingredients

IngredientStrength
GEMCITABINE HYDROCHLORIDE38 mg/mL

OpenFDA Data

SPL SET ID:23b02047-38ea-4dca-875f-3dbcc79e7fec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1719005
  • 1719000
  • 1719003

    • Pharmacological Class

    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Nucleoside Metabolic Inhibitor [EPC]
    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.