Rybrevant Faspro Injection
NDC Package 57894-522-01

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

Package Information

Rybrevant Faspro (amivantamab and hyaluronidase-lpuj (human recombinant)) injection is rYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients. This formulation utilizes a injection delivery system. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-522 and is authorized under FDA application BLA761484.

Identification & Billing

NDC Package Code
57894-522-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 22 mL in 1 VIAL, SINGLE-DOSE
Product Code
57894-522
11-Digit Billing Format
57894052201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2729297 - amivantamab-lpuj 1600 MG / hyaluronidase-lpuj 20000 UNT in 10 ML Injection
  • RxCUI: 2729297 - 10 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection
  • RxCUI: 2729297 - amivantamab-lpuj 1600 MG / hyaluronidase-lpuj 20000 UNT per 10 ML Injection
  • RxCUI: 2729304 - Rybrevant Faspro 1600 MG / 20000 UNT in 10 ML Injection
  • RxCUI: 2729304 - 10 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection [Rybrevant Faspro]

Clinical Specifications

Proprietary Name
Rybrevant Faspro
Non-Proprietary Name
Amivantamab And Hyaluronidase-lpuj (human Recombinant)
Substance Name
Amivantamab; Hyaluronidase (human Recombinant)
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)
Pharmacologic Class
Usage Information
RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.

Regulatory & Marketing

Labeler Name
Janssen Biotech, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761484
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-13-2026
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 57894-522-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 22 ml in 1 vial, single-dose of Rybrevant Faspro, a human prescription drug labeled by Janssen Biotech, Inc.. This injection is formulated for subcutaneous use and contains amivantamab; hyaluronidase (human recombinant) 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 Janssen Biotech, Inc. on February 13, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894052201. 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)
57894-522-01
11-Digit CMS (5-4-2)
57894-0522-01

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