NDC 0078-0567

Afinitor

Everolimus

Afinitor is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Everolimus.

Product ID0078-0567_0ced2a29-15c1-4c3a-b89c-777f1297918c
NDC0078-0567
Product TypeHuman Prescription Drug
Proprietary NameAfinitor
Generic NameEverolimus
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-03-31
Marketing CategoryNDA / NDA
Application NumberNDA022334
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameEVEROLIMUS
Active Ingredient Strength10 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 0078-0567-51

28 BLISTER PACK in 1 CARTON (0078-0567-51) > 1 TABLET in 1 BLISTER PACK (0078-0567-61)
Marketing Start Date2009-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0567-61 [00078056761]

Afinitor TABLET
Marketing CategoryNDA
Application NumberNDA022334
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-22

NDC 0078-0567-51 [00078056751]

Afinitor TABLET
Marketing CategoryNDA
Application NumberNDA022334
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-31

Drug Details

Active Ingredients

IngredientStrength
EVEROLIMUS10 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" or generic name "Everolimus"

    NDCBrand NameGeneric Name
    0078-0594AfinitorAfinitor
    0078-0566AfinitorAfinitor
    0078-0620AfinitorAfinitor
    0078-0567AfinitorAfinitor
    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

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