Uplizna Injection
NDC Package 75987-150-03

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

Package Information

Uplizna (inebilizumab) injection is uPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. This formulation utilizes a injection delivery system. Marketed by Horizon Therapeutics Usa, Inc., this product is identified by NDC 75987-150 and is authorized under FDA application BLA761142.

Identification & Billing

NDC Package Code
75987-150-03
Package Description
3 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (75987-150-01)
Product Code
75987-150
11-Digit Billing Format
75987015003
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Uplizna
Non-Proprietary Name
Inebilizumab
Substance Name
Inebilizumab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
INEBILIZUMAB 10 mg/mL
Pharmacologic Class
Usage Information
UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Regulatory & Marketing

Labeler Name
Horizon Therapeutics Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761142
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-11-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 75987-150-03 identifies a specific commercial package of 3 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (75987-150-01) of Uplizna, a human prescription drug labeled by Horizon Therapeutics Usa, Inc.. This injection is formulated for intravenous use and contains inebilizumab 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 Horizon Therapeutics Usa, Inc. on June 11, 2020. The current certification is valid through December 31, 2026.

How is this Horizon Therapeutics Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75987015003. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
75987-150-03
11-Digit CMS (5-4-2)
75987-0150-03

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