Xdemvy Solution/ Drops
NDC Package 81942-125-99

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

Package Information

Xdemvy (lotilaner ophthalmic solution) solution/ dropses is xDEMVY is indicated for the treatment of Demodex blepharitis. This formulation utilizes a solution/ drops delivery system. Marketed by Tarsus Pharmaceuticals, Inc., this product is identified by NDC 81942-125 and is authorized under FDA application NDA217603.

Identification & Billing

NDC Package Code
81942-125-99
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 1.5 mL in 1 BOTTLE, DROPPER
Product Code
81942-125
11-Digit Billing Format
81942012599
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xdemvy
Non-Proprietary Name
Lotilaner Ophthalmic Solution
Substance Name
Lotilaner
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
LOTILANER 2.5 mg/mL
Pharmacologic Class
Ectoparasiticide - [EPC] (Established Pharmacologic Class)
Usage Information
XDEMVY is indicated for the treatment of Demodex blepharitis.

Regulatory & Marketing

Labeler Name
Tarsus Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA217603
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-14-2023
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81942-125). Click a package code to view its specific billing and regulatory data.

81942-125-01
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

* 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 81942-125-99 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 1.5 ml in 1 bottle, dropper of Xdemvy, a human prescription drug labeled by Tarsus Pharmaceuticals, Inc.. This solution/ drops is formulated for ophthalmic use and contains lotilaner 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 Tarsus Pharmaceuticals, Inc. on August 14, 2023. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81942012599. 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)
81942-125-99
11-Digit CMS (5-4-2)
81942-0125-99

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