"72065-003-01" National Drug Code (NDC)

NDC Code	72065-003-01
Package Description	50 TABLET in 1 BOTTLE (72065-003-01)
Product NDC	72065-003
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Recorlev
Non-Proprietary Name	Levoketoconazole
Dosage Form	TABLET
Usage	ORAL
Start Marketing Date	20211230
Marketing Category Name	NDA
Application Number	NDA214133
Manufacturer	Xeris Pharmaceuticals, Inc.
Substance Name	LEVOKETOCONAZOLE
Strength	150
Strength Unit	mg/1
Pharmacy Classes	Cortisol Synthesis Inhibitor [EPC], Cytochrome P450 11A1 Inhibitors [MoA], Cytochrome P450 11B1 Inhibitors [MoA], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]