beyfortus

Generic: nirsevimab

Labeler: sanofi pasteur inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name beyfortus
Generic Name nirsevimab
Labeler sanofi pasteur inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

nirsevimab 100 mg/mL

Manufacturer
Sanofi Pasteur Inc.

Identifiers & Regulatory

Product NDC 49281-575
Product ID 49281-575_e0a65d86-3032-4442-86be-8bd9f01639e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761328
Listing Expiration 2027-12-31
Marketing Start 2023-07-18

Pharmacologic Class

Established (EPC)
respiratory syncytial virus anti-f protein monoclonal antibody [epc]
Mechanism of Action
fusion protein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49281575
Hyphenated Format 49281-575

Supplemental Identifiers

RxCUI
2642406 2642412 2642414 2642415
UNII
VRN8S9CW5V
NUI
N0000175623 N0000175615

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name beyfortus (source: ndc)
Generic Name nirsevimab (source: ndc)
Application Number BLA761328 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (49281-575-00) / .5 mL in 1 SYRINGE
  • 5 SYRINGE in 1 CARTON (49281-575-15) / .5 mL in 1 SYRINGE
source: ndc

Packages (2)

49281-575-00 1 SYRINGE in 1 CARTON (49281-575-00) / .5 mL in 1 SYRINGE 49281-575-15 5 SYRINGE in 1 CARTON (49281-575-15) / .5 mL in 1 SYRINGE

Ingredients (1)

nirsevimab (100 mg/mL)

Linked Drug Pages (1)

BEYFORTUS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "e0a65d86-3032-4442-86be-8bd9f01639e9", "openfda": {"nui": ["N0000175623", "N0000175615"], "unii": ["VRN8S9CW5V"], "rxcui": ["2642406", "2642412", "2642414", "2642415"], "spl_set_id": ["2f08fa60-f674-432d-801b-1f9514bd9b39"], "pharm_class_epc": ["Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]"], "pharm_class_moa": ["Fusion Protein Inhibitors [MoA]"], "manufacturer_name": ["Sanofi Pasteur Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (49281-575-00)  / .5 mL in 1 SYRINGE", "package_ndc": "49281-575-00", "marketing_start_date": "20230718"}, {"sample": false, "description": "5 SYRINGE in 1 CARTON (49281-575-15)  / .5 mL in 1 SYRINGE", "package_ndc": "49281-575-15", "marketing_start_date": "20230718"}], "brand_name": "BEYFORTUS", "product_id": "49281-575_e0a65d86-3032-4442-86be-8bd9f01639e9", "dosage_form": "INJECTION", "pharm_class": ["Fusion Protein Inhibitors [MoA]", "Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]"], "product_ndc": "49281-575", "generic_name": "nirsevimab", "labeler_name": "Sanofi Pasteur Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BEYFORTUS", "active_ingredients": [{"name": "NIRSEVIMAB", "strength": "100 mg/mL"}], "application_number": "BLA761328", "marketing_category": "BLA", "marketing_start_date": "20230718", "listing_expiration_date": "20271231"}