NDC 55390-391

gemcitabine

Gemcitabine

gemcitabine is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Bedford Laboratories. The primary component is Gemcitabine Hydrochloride.

Product ID55390-391_4cef5f77-82b5-ba03-1f26-4fdeb8af63fd
NDC55390-391
Product TypeHuman Prescription Drug
Proprietary Namegemcitabine
Generic NameGemcitabine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2012-03-19
Marketing CategoryANDA / ANDA
Application NumberANDA091365
Labeler NameBedford Laboratories
Substance NameGEMCITABINE HYDROCHLORIDE
Active Ingredient Strength40 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55390-391-50

1 VIAL, SINGLE-USE in 1 CARTON (55390-391-50) > 25 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2012-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55390-391-10 [55390039110]

gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091365
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-19
Inactivation Date2020-01-31

NDC 55390-391-50 [55390039150]

gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091365
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-19
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GEMCITABINE HYDROCHLORIDE40 mg/mL

OpenFDA Data

SPL SET ID:aa445f68-1e55-a587-76dc-def068bc9c74
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1719000
  • 1719003
  • Pharmacological Class

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

    NDC Crossover Matching brand name "gemcitabine" or generic name "Gemcitabine"

    NDCBrand NameGeneric Name
    0143-9394GemcitabineGemcitabine
    0143-9395GemcitabineGemcitabine
    0409-0181GemcitabineGEMCITABINE
    0409-0182GemcitabineGEMCITABINE
    0409-0183GemcitabineGEMCITABINE
    0409-0185GemcitabineGEMCITABINE
    0409-0186GemcitabineGEMCITABINE
    0409-0187GEMCITABINEGEMCITABINE
    16714-909GEMCITABINEGEMCITABINE HYDROCHLORIDE
    16714-930GEMCITABINEGEMCITABINE HYDROCHLORIDE
    16729-391GEMCITABINEGEMCITABINE
    16729-419GEMCITABINEGEMCITABINE
    16729-423GEMCITABINEGEMCITABINE
    68001-359GEMCITABINEGEMCITABINE
    68001-348GEMCITABINEGEMCITABINE
    68001-342GEMCITABINEGEMCITABINE
    68001-350GEMCITABINEGEMCITABINE
    70860-205GemcitabineGemcitabine
    70860-204GemcitabineGemcitabine
    71288-113GEMCITABINEGEMCITABINE
    71288-114GEMCITABINEGEMCITABINE
    16729-426GEMCITABINEGEMCITABINE
    25021-239GemcitabineGemcitabine
    25021-234gemcitabinegemcitabine
    25021-235gemcitabinegemcitabine
    45963-624GemcitabineGemcitabine
    45963-623GemcitabineGemcitabine
    45963-636GemcitabineGemcitabine
    50742-498GEMCITABINEGEMCITABINE
    50742-497GEMCITABINEGEMCITABINE
    50742-496GEMCITABINEGEMCITABINE
    55111-686gemcitabinegemcitabine
    55111-687gemcitabinegemcitabine
    55390-391gemcitabinegemcitabine
    60505-6114GemcitabineGemcitabine
    60505-6113GemcitabineGemcitabine
    60505-6115GemcitabineGemcitabine
    63323-102GEMCITABINEGEMCITABINE
    63323-125GEMCITABINEGEMCITABINE
    63323-126GEMCITABINEGEMCITABINE
    67457-618GemcitabineGemcitabine
    67457-617GemcitabineGemcitabine
    67457-616GemcitabineGemcitabine

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