"0378-0005-85" National Drug Code (NDC)

Everolimus 4 BLISTER PACK in 1 CARTON (0378-0005-85) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK
(Mylan Pharmaceuticals Inc.)

NDC Code0378-0005-85
Package Description4 BLISTER PACK in 1 CARTON (0378-0005-85) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK
Product NDC0378-0005
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameEverolimus
Non-Proprietary NameEverolimus
Dosage FormTABLET, FOR SUSPENSION
UsageORAL
Start Marketing Date20211001
Marketing Category NameANDA
Application NumberANDA210130
ManufacturerMylan Pharmaceuticals Inc.
Substance NameEVEROLIMUS
Strength2
Strength Unitmg/1
Pharmacy 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]

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