Recorlev
These highlights do not include all the information needed to use RECORLEV safely and effectively. See full prescribing information for RECORLEV. RECORLEV (levoketoconazole) tablets, oral Initial U.S. Approval: 1981 (ketoconazole)
Approved
Approval ID
d4c5fead-bc4a-fb02-e053-2a95a90ae4fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 16, 2023
Manufacturers
FDA
Xeris Pharmaceuticals, Inc.
DUNS: 609377135
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levoketoconazole
PRODUCT DETAILS
NDC Product Code72065-003
Application NumberNDA214133
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 7, 2021
Generic NameLevoketoconazole
INGREDIENTS (1)
LEVOKETOCONAZOLEActive
Quantity: 150 mg in 1 1
Code: 2DJ8R0NT7K
Classification: ACTIB
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 6/30/2023