NDC 0078-0626

Afinitor Disperz

Everolimus

Afinitor Disperz 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 Everolimus.

Product ID0078-0626_0ced2a29-15c1-4c3a-b89c-777f1297918c
NDC0078-0626
Product TypeHuman Prescription Drug
Proprietary NameAfinitor Disperz
Generic NameEverolimus
Dosage FormTablet, For Suspension
Route of AdministrationORAL
Marketing Start Date2012-08-29
Marketing CategoryNDA / NDA
Application NumberNDA203985
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameEVEROLIMUS
Active Ingredient Strength2 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0626-51

28 BLISTER PACK in 1 CARTON (0078-0626-51) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0626-61)
Marketing Start Date2012-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0626-51 [00078062651]

Afinitor Disperz TABLET, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA203985
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-29

NDC 0078-0626-61 [00078062661]

Afinitor Disperz TABLET, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA203985
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-29

Drug Details

Active Ingredients

IngredientStrength
EVEROLIMUS2 mg/1

OpenFDA Data

SPL SET ID:2150f73a-179b-4afc-b8ce-67c85cc72f04
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 998189
  • 1119402
  • 845518
  • 845515
  • 845507
  • 845512
  • 1119400
  • 998191
  • 1308432
  • 1308430
  • 1310138
  • 1310147
  • 1310144
  • 1308428
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Protein Kinase Inhibitors [MoA]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • mTOR Inhibitor Immunosuppressant [EPC]
    • mTOR Inhibitors [MoA]
    • Decreased Immunologic Activity [PE]

    NDC Crossover Matching brand name "Afinitor Disperz" or generic name "Everolimus"

    NDCBrand NameGeneric Name
    0078-0628Afinitor DisperzAfinitor Disperz
    0078-0626Afinitor DisperzAfinitor Disperz
    0078-0627Afinitor DisperzAfinitor Disperz
    0054-0470EverolimusEverolimus
    0054-0471EverolimusEverolimus
    0054-0472EverolimusEverolimus
    0054-0480EverolimusEverolimus
    0054-0481EverolimusEverolimus
    0054-0482EverolimusEverolimus
    0054-0497EverolimusEverolimus
    0054-0604EverolimusEverolimus
    0078-0414Zortresseverolimus
    0078-0415Zortresseverolimus
    0078-0417Zortresseverolimus
    0078-0422Zortresseverolimus

    Trademark Results [Afinitor]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AFINITOR
    AFINITOR
    79059629 3639863 Dead/Cancelled
    Novartis AG
    2008-09-02
    AFINITOR
    AFINITOR
    79023992 3216047 Live/Registered
    Novartis AG
    2006-03-23
    AFINITOR
    AFINITOR
    77675030 3785901 Dead/Cancelled
    Novartis AG
    2009-02-20
    AFINITOR
    AFINITOR
    77540495 3778903 Dead/Cancelled
    Novartis AG
    2008-08-06

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