NDC 0378-0006

Everolimus

Everolimus

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

Product ID0378-0006_ca1a987e-f763-4026-93c5-c545ca95826c
NDC0378-0006
Product TypeHuman Prescription Drug
Proprietary NameEverolimus
Generic NameEverolimus
Dosage FormTablet, For Suspension
Route of AdministrationORAL
Marketing Start Date2021-10-01
Marketing CategoryANDA /
Application NumberANDA210130
Labeler NameMylan Pharmaceuticals Inc.
Substance NameEVEROLIMUS
Active Ingredient Strength3 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 0378-0006-85

4 BLISTER PACK in 1 CARTON (0378-0006-85) > 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK
Marketing Start Date2021-10-01
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
0378-3098everolimuseverolimus
0093-7766EverolimusEverolimus
0378-3097everolimuseverolimus
0093-7767EverolimusEverolimus
0093-7768EverolimusEverolimus
0378-3096everolimuseverolimus
0078-0566Afinitoreverolimus
0078-0567Afinitoreverolimus
0078-0594Afinitoreverolimus
0078-0414Zortresseverolimus
0078-0415Zortresseverolimus
0078-0417Zortresseverolimus
0078-0422Zortresseverolimus

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