FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Recorlev
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOKETOCONAZOLE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2DJ8R0NT7K
Rxcui2588848, 2588854

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
69a83298-cadd-4ff0-88fc-585e3c63aa8bProduct name120220921

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72065-003-012025-08-08C16284748780-13b156c62-2de9-fb37-e063-e6dba90a4e07These 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)
72065-003-012025-08-08C16284748780-13b156c62-2de9-fb37-e063-e6dba90a4e07These 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)
72065-003-012025-07-29C16284748780-13b156c62-2de9-fb37-e063-e6dba90a4e07These 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)
72065-003-012025-07-29C16284748780-13b156c62-2de9-fb37-e063-e6dba90a4e07These 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)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72065-003-01Recorlev50 in 1 BOTTLETABLET5012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72065-003RECORLEV (LEVOKETOCONAZOLE) TABLET [XERIS PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 1 package rows20241205_d4c5fead-bc4a-fb02-e053-2a95a90ae4fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2588848levoketoconazole 150 MG Oral TabletPSNd4c5fead-bc4a-fb02-e053-2a95a90ae4fc12
2588854Recorlev 150 MG Oral TabletPSNd4c5fead-bc4a-fb02-e053-2a95a90ae4fc12
2588854levoketoconazole 150 MG Oral Tablet [Recorlev]SBDd4c5fead-bc4a-fb02-e053-2a95a90ae4fc12
2588848levoketoconazole 150 MG Oral TabletSCDd4c5fead-bc4a-fb02-e053-2a95a90ae4fc12
2588854Recorlev 150 MG Oral TabletSYd4c5fead-bc4a-fb02-e053-2a95a90ae4fc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72065-003-017206500030150 TABLET in 1 BOTTLE (72065-003-01) 50 tablet2021-12-300000-00-00NoNoCurrent