Rybrevant Faspro NDC 57894-522

NDC codes

FDA NDC Directory

Product NDC (as listed)57894-522Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57894-0522Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
57894-522-01	57894052201	1 VIAL, SINGLE-DOSE in 1 CARTON (57894-522-01) / 22 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 13, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Rybrevant Faspro
Generic name (nonproprietary): amivantamab and hyaluronidase-lpuj (human recombinant)
Active ingredients: Amivantamab — 3520 mg/22mLHyaluronidase (Human recombinant) — 44000 mg/22mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Janssen Biotech, Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761433
Marketing start: Feb 13, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Glycoside Hydrolases (Chemical structure)
Identifiers: Product ID 57894-522_b4b42374-17ea-4cc5-8516-3f7731e71bf4SPL ID b4b42374-17ea-4cc5-8516-3f7731e71bf4SPL set ID 9e58b045-e352-4f62-99bf-77fae1bebc69RxCUI 2729297, 2729304, 2729306, 2729307, 2735796, 2735797, 2735803, 2735804UNII 0JSR7Z0NB6, 743QUY4VD8UPC 0357894522010
Pharmacologic class: Endoglycosidase

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N457894052201 followed by a unit qualifier and the quantity

Package 57894-0522-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 17, 2026.

Indications (excerpt from the label)

RYBREVANT FASPRO is a combination of amivantamab, a bispecific EGF receptor-directed and MET receptor-directed antibody, and hyaluronidase, an endoglycosidase indicated: in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. ( 1 , 2.2 ) in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. ( 1 , 2…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761433

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761433
Product	Strength	Form · route	Labeler	Product NDC
Rybrevant Fasproamivantamab and hyaluronidase-lpuj (human recombinant)	Amivantamab 2400 mg/15mL; Hyaluronidase (Human recombinant) 30000 mg/15mL	InjectionSubcutaneous	Janssen Biotech, Inc.	57894-515
Rybrevant Fasproamivantamab and hyaluronidase-lpuj (human recombinant)	Amivantamab 1600 mg/10mL; Hyaluronidase (Human recombinant) 20000 mg/10mL	InjectionSubcutaneous	Janssen Biotech, Inc.	57894-510
Rybrevant Fasproamivantamab and hyaluronidase-lpuj (human recombinant)	Amivantamab 2240 mg/14mL; Hyaluronidase (Human recombinant) 28000 mg/14mL	InjectionSubcutaneous	Janssen Biotech, Inc.	57894-514