FDA.reportPublic FDA data

BEYFORTUS

Product NDC
49281-574
11-digit product format
492810574
Labeler code
49281
Product ID
49281-574_99efb50f-7200-4295-8110-93807f1e8f4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nirsevimab
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Sanofi Vaccines US Inc.
Application
BLA761328
Marketing category
BLA
Marketing start
2023-07-18
Substance
NIRSEVIMAB
Active strength
100 mg/mL
Pharmacologic classes
Fusion Protein Inhibitors [MoA], Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BEYFORTUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIRSEVIMAB100 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-574-15BEYFORTUS1 mL in 1 SYRINGEINJECTION126
49281-574-15BEYFORTUS5 in 1 CARTONINJECTION526
49281-574-88BEYFORTUS1 in 1 CARTONINJECTION126
49281-574-88BEYFORTUS1 mL in 1 SYRINGEINJECTION126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-574-15ML - Milliliter49281-57402a5d2e1-dbd1-4117-9689-e6dc8da26d9112023-09-05
49281-574-88ML - Milliliter49281-5748082f83b-ff25-43d6-a354-b6be5468c68012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-574BEYFORTUS (NIRSEVIMAB) INJECTION [SANOFI PASTEUR INC.]12Current NDC, 4 package rows20250212_2f08fa60-f674-432d-801b-1f9514bd9b39.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BEYFORTUSNIRSEVIMABSanofi Vaccines US Inc.2f08fa60-f674-432d-801b-1f9514bd9b392026-06-26Warnings, Adverse reactionsExact identifier
application number: BLA761328
ndc (product): 49281-574

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761328Beyfortusnirsevimab-alip351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2642415Beyfortus 100 MG in 1 ML Prefilled SyringePSN2f08fa60-f674-432d-801b-1f9514bd9b3926
2642412Beyfortus 50 MG in 0.5 ML Prefilled SyringePSN2f08fa60-f674-432d-801b-1f9514bd9b3926
2642414nirsevimab-alip 100 MG in 1 ML Prefilled SyringePSN2f08fa60-f674-432d-801b-1f9514bd9b3926
2642406nirsevimab-alip 50 MG in 0.5 ML Prefilled SyringePSN2f08fa60-f674-432d-801b-1f9514bd9b3926
26424120.5 ML nirsevimab-alip 100 MG/ML Prefilled Syringe [Beyfortus]SBD2f08fa60-f674-432d-801b-1f9514bd9b3926
26424151 ML nirsevimab-alip 100 MG/ML Prefilled Syringe [Beyfortus]SBD2f08fa60-f674-432d-801b-1f9514bd9b3926
26424060.5 ML nirsevimab-alip 100 MG/ML Prefilled SyringeSCD2f08fa60-f674-432d-801b-1f9514bd9b3926
26424141 ML nirsevimab-alip 100 MG/ML Prefilled SyringeSCD2f08fa60-f674-432d-801b-1f9514bd9b3926
26424120.5 ML Beyfortus 100 MG/ML Prefilled SyringeSY2f08fa60-f674-432d-801b-1f9514bd9b3926
26424151 ML Beyfortus 100 MG/ML Prefilled SyringeSY2f08fa60-f674-432d-801b-1f9514bd9b3926
2642415Beyfortus 100 MG per 1 ML Prefilled SyringeSY2f08fa60-f674-432d-801b-1f9514bd9b3926
2642412Beyfortus 50 MG per 0.5 ML Prefilled SyringeSY2f08fa60-f674-432d-801b-1f9514bd9b3926
2642414nirsevimab-alip 100 MG per 1 ML Prefilled SyringeSY2f08fa60-f674-432d-801b-1f9514bd9b3926
2642406nirsevimab-alip 50 MG per 0.5 ML Prefilled SyringeSY2f08fa60-f674-432d-801b-1f9514bd9b3926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49281-574-15492810574155 SYRINGE in 1 CARTON (49281-574-15) / 1 mL in 1 SYRINGE5 syringe2023-07-18NoNoCurrent
49281-574-88492810574881 SYRINGE in 1 CARTON (49281-574-88) / 1 mL in 1 SYRINGE1 syringe2023-07-18NoNoCurrent