NDC 0054-0604

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 ID0054-0604_0158d8f9-ca9e-46ec-9a66-8cfa40c6c4b0
NDC0054-0604
Product TypeHuman Prescription Drug
Proprietary NameEverolimus
Generic NameEverolimus
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2021-11-18
Marketing CategoryANDA /
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 0054-0604-21

60 TABLET in 1 BOTTLE (0054-0604-21)
Marketing Start Date2021-11-18
NDC Exclude FlagN
Sample Package?N

Drug Details

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
0078-0566Afinitoreverolimus
0078-0414Zortresseverolimus
0078-0415Zortresseverolimus
0078-0417Zortresseverolimus
0078-0422Zortresseverolimus

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