recorlev

Generic: levoketoconazole

Labeler: xeris pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name recorlev
Generic Name levoketoconazole
Labeler xeris pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levoketoconazole 150 mg/1

Manufacturer
Xeris Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72065-003
Product ID 72065-003_9e6fcf1e-f16d-4720-bb12-7e22b8a6d5c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214133
Listing Expiration 2026-12-31
Marketing Start 2021-12-30

Pharmacologic Class

Established (EPC)
cortisol synthesis inhibitor [epc]
Mechanism of Action
cytochrome p450 11b1 inhibitors [moa] cytochrome p450 11a1 inhibitors [moa] cytochrome p450 17a1 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa] organic cation transporter 2 inhibitors [moa] multidrug and toxin extrusion transporter 1 inhibitors [moa] cytochrome p450 2b6 inhibitors [moa] cytochrome p450 2c8 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72065003
Hyphenated Format 72065-003

Supplemental Identifiers

RxCUI
2588848 2588854
UPC
0372065003013
UNII
2DJ8R0NT7K
NUI
N0000193935 N0000193936 N0000193984 N0000182632 N0000182141 N0000185503 N0000187061 N0000191423 N0000182139 N0000187062

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name recorlev (source: ndc)
Generic Name levoketoconazole (source: ndc)
Application Number NDA214133 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE (72065-003-01)
source: ndc

Packages (1)

72065-003-01 50 TABLET in 1 BOTTLE (72065-003-01)

Ingredients (1)

levoketoconazole (150 mg/1)

Linked Drug Pages (1)

Recorlev ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e6fcf1e-f16d-4720-bb12-7e22b8a6d5c7", "openfda": {"nui": ["N0000193935", "N0000193936", "N0000193984", "N0000182632", "N0000182141", "N0000185503", "N0000187061", "N0000191423", "N0000182139", "N0000187062"], "upc": ["0372065003013"], "unii": ["2DJ8R0NT7K"], "rxcui": ["2588848", "2588854"], "spl_set_id": ["d4c5fead-bc4a-fb02-e053-2a95a90ae4fc"], "pharm_class_epc": ["Cortisol Synthesis Inhibitor [EPC]"], "pharm_class_moa": ["Cytochrome P450 11B1 Inhibitors [MoA]", "Cytochrome P450 11A1 Inhibitors [MoA]", "Cytochrome P450 17A1 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]"], "manufacturer_name": ["Xeris Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE (72065-003-01)", "package_ndc": "72065-003-01", "marketing_start_date": "20211230"}], "brand_name": "Recorlev", "product_id": "72065-003_9e6fcf1e-f16d-4720-bb12-7e22b8a6d5c7", "dosage_form": "TABLET", "pharm_class": ["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]"], "product_ndc": "72065-003", "generic_name": "Levoketoconazole", "labeler_name": "Xeris Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Recorlev", "active_ingredients": [{"name": "LEVOKETOCONAZOLE", "strength": "150 mg/1"}], "application_number": "NDA214133", "marketing_category": "NDA", "marketing_start_date": "20211230", "listing_expiration_date": "20261231"}