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NDC 49281-0574-15 BEYFORTUS 100 mg/mL Details
BEYFORTUS 100 mg/mL
BEYFORTUS is a INTRAMUSCULAR INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is NIRSEVIMAB.
MedlinePlus Drug Summary
Nirsevimab-alip is used to prevent lung disease caused by Respiratory Syncytial Virus (RSV) infection in neonates or infants in their first RSV season or for children up to 24 months in their second RSV season and are at risk of severe disease. Nirsevimab-alip is in a class of medications called monoclonal antibodies. It works by preventing RSV from infecting cells and causing disease.
Related Packages: 49281-0574-15Last Updated: 04/14/2024
MedLinePlus Full Drug Details: Nirsevimab-alip
Product Information
| NDC | 49281-0574 |
|---|---|
| Product ID | 49281-574_68042e47-6495-4b99-a244-3360c4e5ce06 |
| Associated GPIs | |
| GCN Sequence Number | 085071 |
| GCN Sequence Number Description | nirsevimab-alip SYRINGE 100 MG/ML INTRAMUSC |
| HIC3 | W5D |
| HIC3 Description | ANTIVIRAL MONOCLONAL ANTIBODIES |
| GCN | 54467 |
| HICL Sequence Number | 049077 |
| HICL Sequence Number Description | NIRSEVIMAB-ALIP |
| Brand/Generic | Brand |
| Proprietary Name | BEYFORTUS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | nirsevimab |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/mL |
| Substance Name | NIRSEVIMAB |
| Labeler Name | Sanofi Pasteur Inc. |
| Pharmaceutical Class | Fusion Protein Inhibitors [MoA], Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761328 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 49281-0574-15 (49281057415)
| NDC Package Code | 49281-574-15 |
|---|---|
| Billing NDC | 49281057415 |
| Package | 5 SYRINGE in 1 CARTON (49281-574-15) / .5 mL in 1 SYRINGE |
| Marketing Start Date | 2023-07-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |