Rybrevant Faspro Injection
NDC Package 57894-522-01
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 BLA761433.
Identification & Billing
- 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
Regulatory & Marketing
Hierarchy Structure
- 57894 - Janssen Biotech, Inc.
- 57894-522 - Rybrevant Faspro
- 57894-522-01 - 1 VIAL, SINGLE-DOSE in 1 CARTON / 22 mL in 1 VIAL, SINGLE-DOSE
- 57894-522 - Rybrevant Faspro
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.
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 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.