NDC 0078-0468

Exjade

Deferasirox

Exjade is a Oral Tablet, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Deferasirox.

Product ID0078-0468_12e80115-bfb7-4292-89cc-e696a3c6c325
NDC0078-0468
Product TypeHuman Prescription Drug
Proprietary NameExjade
Generic NameDeferasirox
Dosage FormTablet, For Suspension
Route of AdministrationORAL
Marketing Start Date2005-11-30
Marketing CategoryNDA / NDA
Application NumberNDA021882
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameDEFERASIROX
Active Ingredient Strength125 mg/1
Pharm ClassesIron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0078-0468-15

30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0468-15)
Marketing Start Date2005-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0468-15 [00078046815]

Exjade TABLET, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA021882
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-11-30

Drug Details

Active Ingredients

IngredientStrength
DEFERASIROX125 mg/1

OpenFDA Data

SPL SET ID:3495a70c-870c-4968-940e-8baea152cf85
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 597768
  • 597772
  • 597770
  • 616161
  • 616163
  • 616159
  • Pharmacological Class

    • Iron Chelating Activity [MoA]
    • Iron Chelator [EPC]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 2C8 Inhibitors [MoA]
    • Cytochrome P450 1A2 Inhibitors [MoA]

    NDC Crossover Matching brand name "Exjade" or generic name "Deferasirox"

    NDCBrand NameGeneric Name
    0078-0468Exjadedeferasirox
    0078-0469Exjadedeferasirox
    0078-0470Exjadedeferasirox
    0078-0654Jadenudeferasirox
    0078-0655Jadenudeferasirox
    0078-0656Jadenudeferasirox

    Trademark Results [Exjade]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EXJADE
    EXJADE
    88575851 not registered Live/Pending
    QINGDAO YUZHUO COSMETIC PRODUCTS CO., LTD
    2019-08-12
    EXJADE
    EXJADE
    78304307 2875038 Live/Registered
    NOVARTIS AG
    2003-09-23
    EXJADE
    EXJADE
    78089460 2773531 Dead/Cancelled
    Novartis AG
    2001-10-22

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