Klisyri Ointment
NDC Package 16110-391-55

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

Klisyri (tirbanibulin) ointment is kLISYRI is indicated for the topical treatment of actinic keratosis on the face or scalp. This formulation utilizes a ointment delivery system. Marketed by Almirall, Llc, this product is identified by NDC 16110-391 and is authorized under FDA application NDA213189.

Identification & Billing

NDC Package Code
16110-391-55
Package Description
5 PACKET in 1 CARTON / .35 g in 1 PACKET
Product Code
16110-391
11-Digit Billing Format
16110039155
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Klisyri
Non-Proprietary Name
Tirbanibulin
Substance Name
Tirbanibulin
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
TIRBANIBULIN 10 mg/g
Pharmacologic Class
Usage Information
KLISYRI is indicated for the topical treatment of actinic keratosis on the face or scalp.

Regulatory & Marketing

Labeler Name
Almirall, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA213189
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-14-2020
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 (16110-391). Click a package code to view its specific billing and regulatory data.

16110-391-05
5 PACKET in 1 CARTON / .25 g in 1 PACKET

* 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 16110-391-55 identifies a specific commercial package of 5 packet in 1 carton / .35 g in 1 packet of Klisyri, a human prescription drug labeled by Almirall, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This ointment is formulated for topical use and contains tirbanibulin 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 Almirall, Llc on December 14, 2020. The current certification is valid through December 31, 2026.

How is this Almirall, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16110039155. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
16110-391-55
11-Digit CMS (5-4-2)
16110-0391-55

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