sarclisa

Generic: isatuximab

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name sarclisa
Generic Name isatuximab
Labeler sanofi-aventis u.s. llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

isatuximab 100 mg/5mL

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-0654
Product ID 0024-0654_847d3ca5-cd5b-4746-93c0-b6bf511d3d13
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761113
Listing Expiration 2026-12-31
Marketing Start 2020-03-02

Pharmacologic Class

Established (EPC)
cd38-directed cytolytic antibody [epc]
Mechanism of Action
cd38-directed antibody interactions [moa]
Chemical Structure
antibodies, monoclonal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00240654
Hyphenated Format 0024-0654

Supplemental Identifiers

RxCUI
2282023 2282028 2282031 2282032
UNII
R30772KCU0
NUI
N0000192336 N0000192335 M0001357

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sarclisa (source: ndc)
Generic Name isatuximab (source: ndc)
Application Number BLA761113 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0654-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0024-0654-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0654-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

isatuximab (100 mg/5mL)

Linked Drug Pages (1)

Sarclisa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "847d3ca5-cd5b-4746-93c0-b6bf511d3d13", "openfda": {"nui": ["N0000192336", "N0000192335", "M0001357"], "unii": ["R30772KCU0"], "rxcui": ["2282023", "2282028", "2282031", "2282032"], "spl_set_id": ["a0473462-6f9d-4eca-a5bf-8620aea68e8a"], "pharm_class_cs": ["Antibodies, Monoclonal [CS]"], "pharm_class_epc": ["CD38-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD38-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0654-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0024-0654-01", "marketing_start_date": "20200302"}], "brand_name": "Sarclisa", "product_id": "0024-0654_847d3ca5-cd5b-4746-93c0-b6bf511d3d13", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Antibodies", "Monoclonal [CS]", "CD38-directed Antibody Interactions [MoA]", "CD38-directed Cytolytic Antibody [EPC]"], "product_ndc": "0024-0654", "generic_name": "isatuximab", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sarclisa", "active_ingredients": [{"name": "ISATUXIMAB", "strength": "100 mg/5mL"}], "application_number": "BLA761113", "marketing_category": "BLA", "marketing_start_date": "20200302", "listing_expiration_date": "20261231"}