NDC 0378-0007

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 ID0378-0007_73b397f2-f490-47e2-b253-8588fc664c0e
NDC0378-0007
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 Strength5 mg/1
Pharm ClassesCytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-0007-85

4 BLISTER PACK in 1 CARTON (0378-0007-85) > 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
0054-0482EverolimusEverolimus
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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.