Package 72065-003-01

Brand: recorlev

Generic: levoketoconazole
NDC Package

Package Facts

Identity

Package NDC 72065-003-01
Digits Only 7206500301
Product NDC 72065-003
Description

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

Marketing

Marketing Status
Marketed Since 2021-12-30
Brand recorlev
Generic levoketoconazole
Sample Package No

Linked Drug Pages (1)

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"}