NDC 71288-113

GEMCITABINE

Gemcitabine Hydrochloride

GEMCITABINE is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is Gemcitabine Hydrochloride.

Product ID71288-113_ac076bca-972b-4521-92cc-d49050babc80
NDC71288-113
Product TypeHuman Prescription Drug
Proprietary NameGEMCITABINE
Generic NameGemcitabine Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA091365
Labeler NameMeitheal Pharmaceuticals Inc.
Substance NameGEMCITABINE HYDROCHLORIDE
Active Ingredient Strength200 mg/1
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71288-113-10

1 VIAL, SINGLE-DOSE in 1 CARTON (71288-113-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71288-113-10 [71288011310]

GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091365
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
GEMCITABINE HYDROCHLORIDE200 mg/1

OpenFDA Data

SPL SET ID:a5949d02-29eb-4626-ad35-b7614bb0fa95
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 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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