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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72065-003
Application NumberNDA214133
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levoketoconazole
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2021
FDA Product Classification
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