Home NDC 0024-0674 Sarclisa Escena
Product NDC 0024-0674
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]
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Sarclisa Escena
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISATUXIMAB 140 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R30772KCU0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2747132 Internal RxNorm lookup 2747135 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761445 Sarclisa Escena isatuximab-irfc 351(a) Rx 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 0024-0674-01 00024067401 1 VIAL in 1 CARTON (0024-0674-01) / 10 mL in 1 VIAL 1 vial 2026-07-09 0 Current