NDC 67457-616

Gemcitabine

Gemcitabine Hydrochloride

Gemcitabine is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Gemcitabine Hydrochloride.

Product ID67457-616_8ce4a4b3-dc6a-49fe-9c1d-291595ccf9f8
NDC67457-616
Product TypeHuman Prescription Drug
Proprietary NameGemcitabine
Generic NameGemcitabine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA205242
Labeler NameMylan Institutional LLC
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 67457-616-10

1 VIAL, SINGLE-DOSE in 1 CARTON (67457-616-10) > 5.26 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-616-10 [67457061610]

Gemcitabine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205242
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-01-03

Drug Details

Active Ingredients

IngredientStrength
GEMCITABINE HYDROCHLORIDE38 mg/mL

OpenFDA Data

SPL SET ID:06dd9d40-74fc-4409-93b1-a46be7126331
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1720975
  • 1720977
  • 1720960
  • Pharmacological Class

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

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

    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
    68001-359GEMCITABINEGEMCITABINE
    68001-348GEMCITABINEGEMCITABINE
    68001-342GEMCITABINEGEMCITABINE
    68001-350GEMCITABINEGEMCITABINE
    70860-205GemcitabineGemcitabine
    70860-204GemcitabineGemcitabine
    71288-113GEMCITABINEGEMCITABINE
    71288-114GEMCITABINEGEMCITABINE
    16729-391GEMCITABINEGEMCITABINE
    16729-419GEMCITABINEGEMCITABINE
    16729-423GEMCITABINEGEMCITABINE
    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
    16729-092GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDE
    0002-7501GemzarGemcitabine hydrochloride
    0002-7502GemzarGemcitabine hydrochloride

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