FDA.reportPublic FDA data

BEYFORTUS

Product NDC
49281-575
11-digit product format
492810575
Labeler code
49281
Product ID
49281-575_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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVRN8S9CW5V
Rxcui2642406, 2642412, 2642414, 2642415

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
49281-575-00BEYFORTUS0.5 mL in 1 SYRINGEINJECTION0.526
49281-575-00BEYFORTUS1 in 1 CARTONINJECTION126
49281-575-15BEYFORTUS0.5 mL in 1 SYRINGEINJECTION0.526
49281-575-15BEYFORTUS5 in 1 CARTONINJECTION526

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-575-00ML - Milliliter49281-575f6e479bf-d89c-47d8-8b8a-89dac509200112023-09-05
49281-575-15ML - Milliliter49281-57558062bc3-db26-4efa-8a86-1e9c85e3c2b012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-575BEYFORTUS (NIRSEVIMAB) INJECTION [SANOFI PASTEUR INC.]12Current NDC, 4 package rows20250212_2f08fa60-f674-432d-801b-1f9514bd9b39.zip

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
49281-575-00492810575001 SYRINGE in 1 CARTON (49281-575-00) / .5 mL in 1 SYRINGE1 syringe2023-07-18NoNoCurrent
49281-575-15492810575155 SYRINGE in 1 CARTON (49281-575-15) / .5 mL in 1 SYRINGE5 syringe2023-07-18NoNoCurrent