NDC 51991-823

Everolimus

Everolimus

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 ID51991-823_95126339-3b9a-42c5-9906-dcaceda4e2d5
NDC51991-823
Product TypeHuman Prescription Drug
Proprietary NameEverolimus
Generic NameEverolimus
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2021-03-05
Marketing CategoryANDA /
Application NumberANDA205426
Labeler NameBreckenridge Pharmaceutical, Inc.
Substance NameEVEROLIMUS
Active Ingredient Strength8 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 51991-823-28

4 BLISTER PACK in 1 CARTON (51991-823-28) > 7 TABLET in 1 BLISTER PACK (51991-823-99)
Marketing Start Date2021-03-05
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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