NDC 16729-423

GEMCITABINE

Gemcitabine

GEMCITABINE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is Gemcitabine Hydrochloride.

Product ID16729-423_7d71b578-f39a-2c23-e053-2991aa0a1272
NDC16729-423
Product TypeHuman Prescription Drug
Proprietary NameGEMCITABINE
Generic NameGemcitabine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-01-24
Marketing CategoryNDA / NDA
Application NumberNDA209604
Labeler NameAccord Healthcare Inc.
Substance NameGEMCITABINE HYDROCHLORIDE
Active Ingredient Strength100 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 16729-423-33

15 mL in 1 VIAL, MULTI-DOSE (16729-423-33)
Marketing Start Date2018-01-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-423-33 [16729042333]

GEMCITABINE INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA209604
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-01-24

Drug Details

Active Ingredients

IngredientStrength
GEMCITABINE HYDROCHLORIDE100 mg/mL

OpenFDA Data

SPL SET ID:5a335d36-408b-478f-9563-4bc140b69bb6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1998783
  • UPC Code
  • 0316729391306
  • 0316729426053
  • 0316729419031
  • 0316729423335
  • 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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