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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIRSEVIMAB100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VRN8S9CW5VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2642406Internal RxNorm lookup
2642412Internal RxNorm lookup
2642414Internal RxNorm lookup
2642415Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f08fa60-f674-432d-801b-1f9514bd9b39Available on FDA.report

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761328Beyfortusnirsevimab-alip351(a)Rx2026-06-01

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