NDC 0004-1101

Xeloda

Capecitabine

Xeloda is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Capecitabine.

Product ID0004-1101_291d4df7-44eb-4bc6-a04e-e057cac12144
NDC0004-1101
Product TypeHuman Prescription Drug
Proprietary NameXeloda
Generic NameCapecitabine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1998-04-30
Marketing CategoryNDA / NDA
Application NumberNDA020896
Labeler NameGenentech, Inc.
Substance NameCAPECITABINE
Active Ingredient Strength500 mg/1
Pharm ClassesNucleic Acid Sy
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0004-1101-50

120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-1101-50)
Marketing Start Date1998-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0004-1101-75 [00004110175]

Xeloda TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020896
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-04-30
Marketing End Date2014-12-31

NDC 0004-1101-51 [00004110151]

Xeloda TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020896
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-05
Marketing End Date2011-12-20

NDC 0004-1101-50 [00004110150]

Xeloda TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020896
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-04-30

Drug Details

Active Ingredients

IngredientStrength
CAPECITABINE500 mg/1

OpenFDA Data

SPL SET ID:a1de8bba-3b1d-4c9d-ab8a-32d2c05e67c8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200328
  • 213293
  • 200327
  • 213292
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Xeloda" or generic name "Capecitabine"

    NDCBrand NameGeneric Name
    0004-1100Xelodacapecitabine
    0004-1101Xelodacapecitabine
    53808-0411XelodaXeloda
    0054-0271CapecitabineCapecitabine
    0054-0272CapecitabineCapecitabine
    0093-7473CapecitabineCapecitabine
    0093-7474CapecitabineCapecitabine
    0378-2511Capecitabinecapecitabine
    0378-2512Capecitabinecapecitabine
    16714-467CAPECITABINECAPECITABINE

    Trademark Results [Xeloda]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XELODA
    XELODA
    75241696 2200434 Live/Registered
    Hoffmann-La Roche Inc.
    1997-02-13

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.