NDC 0378-3099

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 ID0378-3099_d51ed68d-10ee-4bbc-9c97-869744f060dc
NDC0378-3099
Product TypeHuman Prescription Drug
Proprietary Nameeverolimus
Generic NameEverolimus
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-12-15
Marketing CategoryANDA /
Application NumberANDA212936
Labeler NameMylan Pharmaceuticals Inc.
Substance NameEVEROLIMUS
Active Ingredient Strength10 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 0378-3099-85

4 BLISTER PACK in 1 CARTON (0378-3099-85) > 7 TABLET in 1 BLISTER PACK (0378-3099-32)
Marketing Start Date2022-12-15
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
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