"0378-3097-85" National Drug Code (NDC)

Everolimus 4 BLISTER PACK in 1 CARTON (0378-3097-85) / 7 TABLET in 1 BLISTER PACK (0378-3097-32)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-3097-85
Package Description4 BLISTER PACK in 1 CARTON (0378-3097-85) / 7 TABLET in 1 BLISTER PACK (0378-3097-32)
Product NDC0378-3097
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameEverolimus
Non-Proprietary NameEverolimus
Dosage FormTABLET
UsageORAL
Start Marketing Date20221215
Marketing Category NameANDA
Application NumberANDA212936
ManufacturerMylan Pharmaceuticals Inc.
Substance NameEVEROLIMUS
Strength5
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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