Beyfortus (nirsevimab) NDC 49281-574

NDC codes

FDA NDC Directory

Product NDC (as listed)49281-574Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49281-0574Add 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
49281-574-15	49281057415	5 SYRINGE in 1 CARTON (49281-574-15) / 1 mL in 1 SYRINGEMarketed from Jul 18, 2023
49281-574-88	49281057488	1 SYRINGE in 1 CARTON (49281-574-88) / 1 mL in 1 SYRINGEMarketed from Jul 18, 2023

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): Beyfortus
Generic name (nonproprietary): nirsevimab
Active ingredients: Nirsevimab — 100 mg/mL
Dosage form: Injection
Route: Intramuscular
Labeler: Sanofi Vaccines US Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761328
Marketing start: Jul 18, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Fusion Protein Inhibitors (Mechanism)
Identifiers: Product ID 49281-574_7d00fab8-90a7-4e7f-b6d5-e1a7c8bd5933SPL ID 7d00fab8-90a7-4e7f-b6d5-e1a7c8bd5933SPL set ID 2f08fa60-f674-432d-801b-1f9514bd9b39RxCUI 2642406, 2642412, 2642414, 2642415UNII VRN8S9CW5V
Pharmacologic class: Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody

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

N449281057415 followed by a unit qualifier and the quantity

Package 49281-0574-15. 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 Jul 13, 2026.

Indications (excerpt from the label)

BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. BEYFORTUS is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. ( 1 ) Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761328

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

FDA NDC Directory listings under BLA 761328
Product	Strength	Form · route	Labeler	Product NDC
Beyfortusnirsevimab	Nirsevimab 100 mg/mL	InjectionIntramuscular	Sanofi Vaccines US Inc.	49281-575