FDA.reportPublic FDA data

Sarclisa

Product NDC
0024-0656
11-digit product format
000240656
Labeler code
0024
Product ID
0024-0656_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
500 mg/25mL
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISATUXIMAB500 mg/25mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR30772KCU0
Rxcui2282023, 2282028, 2282031, 2282032

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
0024-0656-012024-01-30C16284748780-11030e365-45db-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
0024-0656-01Sarclisa1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE117
0024-0656-01Sarclisa25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE2517

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-0656SARCLISA (ISATUXIMAB) INJECTION, SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]16Current NDC, Legacy NDC, 2 package rows20241108_a0473462-6f9d-4eca-a5bf-8620aea68e8a.zip

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
0024-0656-01000240656011 VIAL, SINGLE-DOSE in 1 CARTON (0024-0656-01) / 25 mL in 1 VIAL, SINGLE-DOSE2020-03-020000-00-00NoNoCurrent