FDA.reportPublic FDA data

Sarclisa

Product NDC
0024-0654
11-digit product format
000240654
Labeler code
0024
Product ID
0024-0654_847d3ca5-cd5b-4746-93c0-b6bf511d3d13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isatuximab
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Sanofi-Aventis U.S. LLC
Application
BLA761113
Marketing category
BLA
Marketing start
2020-03-02
Substance
ISATUXIMAB
Active strength
100 mg/5mL
Pharmacologic classes
Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISATUXIMAB100 mg/5mL

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2282023Internal RxNorm lookup
2282028Internal RxNorm lookup
2282031Internal RxNorm lookup
2282032Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0473462-6f9d-4eca-a5bf-8620aea68e8aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a77fe3ea-2821-49df-840d-55d5e3c6d59dProduct name120200701
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0024-0654-012024-01-30C16284748780-11030e365-45db-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SARCLISA safely and effectively. See full prescribing information for SARCLISA. SARCLISA ® (isatuximab-irfc) injection, for intravenous use Initial U.S. Approval: 2020
0024-0654-012024-01-30C16284748780-11030e365-45db-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SARCLISA safely and effectively. See full prescribing information for SARCLISA. SARCLISA ® (isatuximab-irfc) injection, for intravenous use Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-0654-01Sarclisa1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE117
0024-0654-01Sarclisa5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-0654-01ML - Milliliter0024-06546448fc06-fefc-429b-86f6-3961cf63a67a12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-0654SARCLISA (ISATUXIMAB) INJECTION, SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]16Current NDC, Legacy NDC, 2 package rows20241108_a0473462-6f9d-4eca-a5bf-8620aea68e8a.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
SarclisaISATUXIMABSanofi-Aventis U.S. LLCa0473462-6f9d-4eca-a5bf-8620aea68e8a2026-07-07Warnings, Adverse reactionsExact identifier
application number: BLA761113
ndc (product): 0024-0654

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761113Sarclisaisatuximab-irfc351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2282023isatuximab-irfc 100 MG in 5 ML InjectionPSNa0473462-6f9d-4eca-a5bf-8620aea68e8a17
2282031isatuximab-irfc 500 MG in 25 ML InjectionPSNa0473462-6f9d-4eca-a5bf-8620aea68e8a17
2282028SARCLISA 100 MG in 5 ML InjectionPSNa0473462-6f9d-4eca-a5bf-8620aea68e8a17
2282032SARCLISA 500 MG in 25 ML InjectionPSNa0473462-6f9d-4eca-a5bf-8620aea68e8a17
228203225 ML isatuximab-irfc 20 MG/ML Injection [Sarclisa]SBDa0473462-6f9d-4eca-a5bf-8620aea68e8a17
22820285 ML isatuximab-irfc 20 MG/ML Injection [Sarclisa]SBDa0473462-6f9d-4eca-a5bf-8620aea68e8a17
228203125 ML isatuximab-irfc 20 MG/ML InjectionSCDa0473462-6f9d-4eca-a5bf-8620aea68e8a17
22820235 ML isatuximab-irfc 20 MG/ML InjectionSCDa0473462-6f9d-4eca-a5bf-8620aea68e8a17
228203225 ML Sarclisa 20 MG/ML InjectionSYa0473462-6f9d-4eca-a5bf-8620aea68e8a17
22820285 ML Sarclisa 20 MG/ML InjectionSYa0473462-6f9d-4eca-a5bf-8620aea68e8a17
2282023isatuximab-irfc 100 MG per 5 ML InjectionSYa0473462-6f9d-4eca-a5bf-8620aea68e8a17
2282031isatuximab-irfc 500 MG per 25 ML InjectionSYa0473462-6f9d-4eca-a5bf-8620aea68e8a17
2282028Sarclisa 100 MG per 5 ML InjectionSYa0473462-6f9d-4eca-a5bf-8620aea68e8a17
2282032Sarclisa 500 MG per 25 ML InjectionSYa0473462-6f9d-4eca-a5bf-8620aea68e8a17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0024-0654-01000240654011 VIAL, SINGLE-DOSE in 1 CARTON (0024-0654-01) / 5 mL in 1 VIAL, SINGLE-DOSE2020-03-020000-00-00NoNoCurrent