recorlev (72065-003) | FunFoxMeds NDC

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_ed08de98-fda5-455e-94b3-79ebf1c046cd

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA214133

Listing Expiration 2027-12-31

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

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": "ed08de98-fda5-455e-94b3-79ebf1c046cd", "openfda": {"nui": ["N0000193935", "N0000193936", "N0000193984", "N0000182632", "N0000182141", "N0000185503", "N0000187061", "N0000191423", "N0000182139", "N0000187062"], "upc": ["0372065003013"], "unii": ["2DJ8R0NT7K"], "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_ed08de98-fda5-455e-94b3-79ebf1c046cd", "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": "20271231"}