Ocrevus Zunovo Injection, Solution
NDC Package 50242-554-01

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

Package Information

Ocrevus Zunovo (ocrelizumab and hyaluronidase) injection is oCREVUS ZUNOVO is indicated for the treatment of:Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adultsPrimary progressive MS, in adults. This formulation utilizes a injection, solution delivery system. Marketed by Genentech, Inc., this product is identified by NDC 50242-554 and is authorized under FDA application BLA761371.

Identification & Billing

NDC Package Code
50242-554-01
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 23 mL in 1 VIAL, SINGLE-USE
Product Code
50242-554
11-Digit Billing Format
50242055401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2693458 - ocrelizumab-ocsq 920 MG / hyaluronidase-ocsq 23,000 UNT in 23 ML Injection
  • RxCUI: 2693458 - 23 ML hyaluronidase-ocsq 1000 UNT/ML / ocrelizumab-ocsq 40 MG/ML Injection
  • RxCUI: 2693458 - ocrelizumab-hyaluronidase-ocsq 920 MG / 23,000 UNT per 23 ML Injection
  • RxCUI: 2693458 - ocrelizumab-ocsq 920 MG / hyaluronidase-ocsq 23,000 UNT per 23 ML Injection
  • RxCUI: 2693465 - Ocrevus Zunovo 920 MG / 23,000 UNT in 23 ML Injection

Clinical Specifications

Proprietary Name
Ocrevus Zunovo
Non-Proprietary Name
Ocrelizumab And Hyaluronidase
Substance Name
Hyaluronidase (human Recombinant); Ocrelizumab
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)
Pharmacologic Class
Usage Information
OCREVUS ZUNOVO is indicated for the treatment of:Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adultsPrimary progressive MS, in adults

Regulatory & Marketing

Labeler Name
Genentech, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761371
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-13-2024
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.

J2351
Source: ASP
Inj ocrelizumab 1mg hya-ocsq
HCPCS Dosage 1 MG
Units / Pkg 920

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50242-554). Click a package code to view its specific billing and regulatory data.

50242-554-86
1 VIAL, SINGLE-USE in 1 CARTON / 23 mL in 1 VIAL, SINGLE-USE

* 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 50242-554-01 identifies a specific commercial package of 1 vial, single-use in 1 carton / 23 ml in 1 vial, single-use of Ocrevus Zunovo, a human prescription drug labeled by Genentech, Inc.. This injection, solution is formulated for subcutaneous use and contains hyaluronidase (human recombinant); ocrelizumab 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 Genentech, Inc. on September 13, 2024. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50242055401. 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)
50242-554-01
11-Digit CMS (5-4-2)
50242-0554-01

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