NDC 0054-0472

Everolimus

Everolimus

Everolimus is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Everolimus.

Product ID0054-0472_0158d8f9-ca9e-46ec-9a66-8cfa40c6c4b0
NDC0054-0472
Product TypeHuman Prescription Drug
Proprietary NameEverolimus
Generic NameEverolimus
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-03-10
Marketing CategoryANDA / ANDA
Application NumberANDA206133
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameEVEROLIMUS
Active Ingredient Strength1 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 Through2022-12-31

Packaging

NDC 0054-0472-21

60 TABLET in 1 BOTTLE (0054-0472-21)
Marketing Start Date2020-03-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0472-21 [00054047221]

Everolimus TABLET
Marketing CategoryANDA
Application NumberANDA206133
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-10

Drug Details

Active Ingredients

IngredientStrength
EVEROLIMUS.75 mg/1

OpenFDA Data

SPL SET ID:cf2dd54b-7a1d-4401-9a01-75e68235e433
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977438
  • 977434
  • 977427
  • 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 "Everolimus" or generic name "Everolimus"

    NDCBrand NameGeneric Name
    0054-0470EverolimusEverolimus
    0054-0471EverolimusEverolimus
    0054-0472EverolimusEverolimus
    0054-0480EverolimusEverolimus
    0054-0481EverolimusEverolimus
    0054-0482EverolimusEverolimus
    0054-0497EverolimusEverolimus
    0054-0604EverolimusEverolimus
    49884-119EverolimusEverolimus
    49884-127EverolimusEverolimus
    49884-125EverolimusEverolimus
    0378-3098everolimuseverolimus
    0093-7766EverolimusEverolimus
    0378-3097everolimuseverolimus
    0093-7767EverolimusEverolimus
    0093-7768EverolimusEverolimus
    0378-3096everolimuseverolimus
    0078-0414Zortresseverolimus
    0078-0415Zortresseverolimus
    0078-0417Zortresseverolimus
    0078-0422Zortresseverolimus

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