NDC 0078-0655

Jadenu

Deferasirox

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

Product ID0078-0655_19ac4728-bb03-46b7-8221-28c2a43bc913
NDC0078-0655
Product TypeHuman Prescription Drug
Proprietary NameJadenu
Generic NameDeferasirox
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-03-30
Marketing CategoryNDA / NDA
Application NumberNDA206910
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameDEFERASIROX
Active Ingredient Strength180 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 0078-0655-15

30 TABLET, FILM COATED in 1 BOTTLE (0078-0655-15)
Marketing Start Date2015-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0655-15 [00078065515]

Jadenu TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206910
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-30

Drug Details

Active Ingredients

IngredientStrength
DEFERASIROX180 mg/1

OpenFDA Data

SPL SET ID:fee89140-fff1-4443-9f42-24ac004fcda1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1923829
  • 1923825
  • 1923828
  • 1607790
  • 1607792
  • 1607794
  • 1607796
  • 1607798
  • 1607784
  • 1923822
  • 1923826
  • 1923827
  • 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 "Jadenu" or generic name "Deferasirox"

    NDCBrand NameGeneric Name
    0078-0654Jadenudeferasirox
    0078-0655Jadenudeferasirox
    0078-0656Jadenudeferasirox
    0078-0713JadenuJadenu
    0078-0720JadenuJadenu
    0078-0727JadenuJadenu
    0078-0468Exjadedeferasirox
    0078-0469Exjadedeferasirox
    0078-0470Exjadedeferasirox

    Trademark Results [Jadenu]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    JADENU
    JADENU
    86180574 4800484 Live/Registered
    Novartis AG
    2014-01-31

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