Recorlev Tablet
NDC Package 72065-003-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Recorlev (levoketoconazole) tablets is rECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.Limitations of UseRECORLEV is not approved for the treatment of fungal infections. This formulation utilizes a tablet delivery system. Marketed by Xeris Pharmaceuticals, Inc., this product is identified by NDC 72065-003 and is authorized under FDA application NDA214133.

Identification & Billing

NDC Package Code
72065-003-01
Package Description
50 TABLET in 1 BOTTLE
Product Code
72065-003
11-Digit Billing Format
72065000301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
50 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Recorlev
Non-Proprietary Name
Levoketoconazole
Substance Name
Levoketoconazole
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LEVOKETOCONAZOLE 150 mg/1
Pharmacologic Class
Usage Information
RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative.Limitations of UseRECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established.

Regulatory & Marketing

Labeler Name
Xeris Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214133
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-30-2021
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72065-003-01 identifies a specific commercial package of 50 tablet in 1 bottle of Recorlev, a human prescription drug labeled by Xeris Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 50 billable units per package. This tablet is formulated for oral use and contains levoketoconazole as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Xeris Pharmaceuticals, Inc. on December 30, 2021. The current certification is valid through December 31, 2027.

How is this Xeris Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72065000301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 50 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
72065-003-01
11-Digit CMS (5-4-2)
72065-0003-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.