Leqselvi Tablet, Film Coated
NDC Package 47335-108-86

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

Package Information

Leqselvi (deuruxolitinib phosphate) tablets is lEQSELVI™ is indicated for the treatment of adult patients with severe alopecia areata. This formulation utilizes a tablet, film coated delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 47335-108 and is authorized under FDA application NDA217900.

Identification & Billing

NDC Package Code
47335-108-86
Package Description
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
47335-108
11-Digit Billing Format
47335010886
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Leqselvi
Non-Proprietary Name
Deuruxolitinib Phosphate
Substance Name
Deuruxolitinib Phosphate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEURUXOLITINIB PHOSPHATE 8 mg/1
Pharmacologic Class
Usage Information
LEQSELVI™ is indicated for the treatment of adult patients with severe alopecia areata. Limitations of UseLEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA217900
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-25-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 47335-108-86 identifies a specific commercial package of 60 tablet, film coated in 1 bottle, plastic of Leqselvi, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet, film coated is formulated for oral use and contains deuruxolitinib phosphate 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 Sun Pharmaceutical Industries, Inc. on June 25, 2025. The current certification is valid through December 31, 2026.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335010886. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
47335-108-86
11-Digit CMS (5-4-2)
47335-0108-86

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