NDC 51991-380

Everolimus

Everolimus Tablets

Everolimus is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Everolimus.

Product ID51991-380_294fa133-6d0c-4813-ac01-523164eb9663
NDC51991-380
Product TypeHuman Prescription Drug
Proprietary NameEverolimus
Generic NameEverolimus Tablets
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2021-05-21
Marketing CategoryANDA /
Application NumberANDA205432
Labeler NameBreckenridge Pharmaceutical, 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 51991-380-60

60 BLISTER PACK in 1 CARTON (51991-380-60) > 10 TABLET in 1 BLISTER PACK (51991-380-99)
Marketing Start Date2021-05-21
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Everolimus" or generic name "Everolimus Tablets"

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.