NDC 0378-3098

everolimus

Everolimus

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

Product ID0378-3098_b7c7c9a4-994f-43dc-8cd6-cd6eeed6fa89
NDC0378-3098
Product TypeHuman Prescription Drug
Proprietary Nameeverolimus
Generic NameEverolimus
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-09-10
Marketing CategoryANDA /
Application NumberANDA212936
Labeler NameMylan Pharmaceuticals Inc.
Substance NameEVEROLIMUS
Active Ingredient Strength8 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 0378-3098-85

4 BLISTER PACK in 1 CARTON (0378-3098-85) > 7 TABLET in 1 BLISTER PACK (0378-3098-32)
Marketing Start Date2020-09-10
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
0054-0497EverolimusEverolimus
49884-119EverolimusEverolimus
49884-127EverolimusEverolimus
49884-125EverolimusEverolimus
0078-0566Afinitoreverolimus
0078-0567Afinitoreverolimus
0078-0594Afinitoreverolimus
0078-0620Afinitoreverolimus
0078-0626Afinitoreverolimus
0078-0627Afinitoreverolimus
0078-0414Zortresseverolimus
0078-0415Zortresseverolimus
0078-0417Zortresseverolimus
0078-0422Zortresseverolimus

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