Spevigo Injection
NDC Package 50222-360-72

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

Package Information

Spevigo (spesolimab) injection is sPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. This formulation utilizes a injection delivery system. Marketed by Leo Pharma Inc., this product is identified by NDC 50222-360 and is authorized under FDA application BLA761244.

Identification & Billing

NDC Package Code
50222-360-72
Package Description
2 VIAL, GLASS in 1 CARTON / 7.5 mL in 1 VIAL, GLASS
Product Code
50222-360
11-Digit Billing Format
50222036072
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Spevigo
Non-Proprietary Name
Spesolimab
Substance Name
Spesolimab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
SPESOLIMAB 60 mg/mL
Pharmacologic Class
Usage Information
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.

Regulatory & Marketing

Labeler Name
Leo Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761244
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-09-2026
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 50222-360-72 identifies a specific commercial package of 2 vial, glass in 1 carton / 7.5 ml in 1 vial, glass of Spevigo, a human prescription drug labeled by Leo Pharma Inc.. This injection is formulated for subcutaneous use and contains spesolimab 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 Leo Pharma Inc. on March 09, 2026. The current certification is valid through December 31, 2027.

How is this Leo Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50222036072. 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)
50222-360-72
11-Digit CMS (5-4-2)
50222-0360-72

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