Home NDC 72065-003 Recorlev
Product NDC 72065-003
11-digit product format 720650003
Labeler code 72065
Product ID 72065-003_ed08de98-fda5-455e-94b3-79ebf1c046cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levoketoconazole
Dosage form TABLET
Route ORAL
Labeler Xeris Pharmaceuticals, Inc.
Application NDA214133
Marketing category NDA
Marketing start 2021-12-30
Substance LEVOKETOCONAZOLE
Active strength 150 mg/1
Pharmacologic 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]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72065-003-01 Recorlev 50 in 1 BOTTLE TABLET 50 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72065-003 RECORLEV (LEVOKETOCONAZOLE) TABLET [XERIS PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20241205_d4c5fead-bc4a-fb02-e053-2a95a90ae4fc.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72065-003-01 72065000301 50 TABLET in 1 BOTTLE (72065-003-01) 50 tablet 2021-12-30 0000-00-00 No No Current