Rystiggo Injection, Solution
NDC Package 50474-982-84

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

Package Information

Rystiggo (rozanolixizumab) injection is rYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. This formulation utilizes a injection, solution delivery system. Marketed by Ucb, Inc., this product is identified by NDC 50474-982 and is authorized under FDA application BLA761286.

Identification & Billing

NDC Package Code
50474-982-84
Package Description
1 VIAL, GLASS in 1 CARTON / 4 mL in 1 VIAL, GLASS
Product Code
50474-982
11-Digit Billing Format
50474098284
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rystiggo
Non-Proprietary Name
Rozanolixizumab
Substance Name
Rozanolixizumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ROZANOLIXIZUMAB 140 mg/mL
Pharmacologic Class
Usage Information
RYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Regulatory & Marketing

Labeler Name
Ucb, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761286
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-14-2024
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9333
Source: ASP
Inj rozanolixizum-noli 1 mg
HCPCS Dosage 1 MG
Units / Pkg 560

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 50474-982-84 identifies a specific commercial package of 1 vial, glass in 1 carton / 4 ml in 1 vial, glass of Rystiggo, a human prescription drug labeled by Ucb, Inc.. This injection, solution is formulated for subcutaneous use and contains rozanolixizumab 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 Ucb, Inc. on June 14, 2024. The current certification is valid through December 31, 2027.

How is this Ucb, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50474098284. 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)
50474-982-84
11-Digit CMS (5-4-2)
50474-0982-84

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