Lupkynis
NDC Package 75626-001-02

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Lupkynis is indicated in combination with a background immunosuppressive therapy regimen [see Clinical Studies (14)] for the treatment of adult patients with active lupus nephritis (LN).Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Marketed by Aurinia Pharma U.s., Inc., this product is identified by NDC 75626-001 and is authorized under FDA application NDA213716.

Identification & Billing

NDC Package Code
75626-001-02
Package Description
3 PACKET in 1 CARTON / 4 BLISTER PACK in 1 PACKET (75626-001-01) / 15 CAPSULE in 1 BLISTER PACK
Product Code
75626-001
11-Digit Billing Format
75626000102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lupkynis
Dosage Form
-
Usage Information
LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen [see Clinical Studies (14)] for the treatment of adult patients with active lupus nephritis (LN).Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

Regulatory & Marketing

Labeler Name
Aurinia Pharma U.s., Inc.
FDA Application #
NDA213716
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-22-2021
Listing Expiration
12-31-2026
Exclude Flag
I
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 75626-001-02 identifies a specific commercial package of 3 packet in 1 carton / 4 blister pack in 1 packet (75626-001-01) / 15 capsule in 1 blister pack of Lupkynis, labeled by Aurinia Pharma U.s., Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aurinia Pharma U.s., Inc. on January 22, 2021. The current certification is valid through December 31, 2026.

How is this Aurinia Pharma U.s., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75626000102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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)
75626-001-02
11-Digit CMS (5-4-2)
75626-0001-02

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