NDC 0078-0417

Zortress

Everolimus

Zortress 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 ID0078-0417_003fbaa6-1698-4767-9222-2e5735085502
NDC0078-0417
Product TypeHuman Prescription Drug
Proprietary NameZortress
Generic NameEverolimus
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-04-22
Marketing CategoryNDA / NDA
Application NumberNDA021560
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameEVEROLIMUS
Active Ingredient Strength0 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 Through2019-12-31

Packaging

NDC 0078-0417-20

60 BLISTER PACK in 1 BOX (0078-0417-20) > 1 TABLET in 1 BLISTER PACK (0078-0417-61)
Marketing Start Date2010-04-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0417-61 [00078041761]

Zortress TABLET
Marketing CategoryNDA
Application NumberNDA021560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-22

NDC 0078-0417-20 [00078041720]

Zortress TABLET
Marketing CategoryNDA
Application NumberNDA021560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-22

Drug Details

Active Ingredients

IngredientStrength
EVEROLIMUS.25 mg/1

OpenFDA Data

SPL SET ID:e082a024-7850-400b-a5c2-2a140612562a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2056895
  • 2056897
  • 977438
  • 977427
  • 977431
  • 977436
  • 977434
  • 977440
  • 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 "Zortress" or generic name "Everolimus"

    NDCBrand NameGeneric Name
    0078-0414Zortresseverolimus
    0078-0415Zortresseverolimus
    0078-0417Zortresseverolimus
    0078-0422Zortresseverolimus
    0054-0470EverolimusEverolimus
    0054-0471EverolimusEverolimus
    0054-0472EverolimusEverolimus
    0054-0480EverolimusEverolimus
    0054-0481EverolimusEverolimus
    0054-0482EverolimusEverolimus
    0054-0497EverolimusEverolimus
    0054-0604EverolimusEverolimus

    Trademark Results [Zortress]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZORTRESS
    ZORTRESS
    79040925 3379019 Live/Registered
    Novartis AG
    2006-12-20
    ZORTRESS
    ZORTRESS
    78058595 2607670 Dead/Cancelled
    Novartis AG
    2001-04-16
    ZORTRESS
    ZORTRESS
    77912850 3945609 Live/Registered
    Novartis AG
    2010-01-15

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