FDA.reportPublic FDA data

Sarclisa Escena

Product NDC
0024-0674
Requested package NDC
0024-0674-01
11-digit product format
000240674
Labeler code
0024
Product ID
0024-0674_564889eb-80a7-336a-e063-6294a90a30c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isatuximab-irfc
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sanofi-Aventis U.S. LLC
Application
BLA761445
Marketing category
BLA
Marketing start
2026-07-09
Substance
ISATUXIMAB
Active strength
140 mg/mL
Pharmacologic classes
Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISATUXIMAB140 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R30772KCU0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2747132Internal RxNorm lookup
2747135Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
07730e8c-1340-4d30-8d71-e20f850db8daAvailable on FDA.report

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
Sarclisa EscenaISATUXIMAB-IRFCSanofi-Aventis U.S. LLC07730e8c-1340-4d30-8d71-e20f850db8da2026-07-10Warnings, Adverse reactionsExact identifier
application number: BLA761445
ndc (package): 0024-0674-01
ndc (product): 0024-0674
ndc11 (package): 00024067401

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761445Sarclisa Escenaisatuximab-irfc351(a)Rx2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0024-0674-01000240674011 VIAL in 1 CARTON (0024-0674-01) / 10 mL in 1 VIAL1 vial2026-07-09NoNoCurrent