"0054-0497-13" National Drug Code (NDC)

Everolimus 30 TABLET in 1 BOTTLE (0054-0497-13)
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0497-13
Package Description30 TABLET in 1 BOTTLE (0054-0497-13)
Product NDC0054-0497
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameEverolimus
Non-Proprietary NameEverolimus
Dosage FormTABLET
UsageORAL
Start Marketing Date20200608
Marketing Category NameANDA
Application NumberANDA207486
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameEVEROLIMUS
Strength7.5
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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