NDC 0024-0654

Sarclisa

Isatuximab

Sarclisa is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Sanof-aventis U.s. Llc. The primary component is Isatuximab.

• Product ID: 0024-0654_1954b45c-23b6-4de5-a540-f9be3a347da4
• NDC: 0024-0654
• Product Type: Human Prescription Drug
• Proprietary Name: Sarclisa
• Generic Name: Isatuximab
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-03-02
• Marketing Category: BLA / BLA
• Application Number: BLA761113
• Labeler Name: sanof-aventis U.S. LLC
• Substance Name: ISATUXIMAB
• Active Ingredient Strength: 100 mg/5mL
• Pharm Classes: Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0024-0654-01

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

• Marketing Start Date: 2020-03-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0024-0654-01 [00024065401]

Sarclisa INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA761113
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-03-02

Drug Details

Active Ingredients

Ingredient	Strength
ISATUXIMAB	100 mg/5mL

OpenFDA Data

• SPL SET ID: a0473462-6f9d-4eca-a5bf-8620aea68e8a
• Manufacturer:
  • sanof-aventis U.S. LLC
• UNII:
  • R30772KCU0
• RxNorm Concept Unique ID - RxCUI:
  • 2282023
  • 2282031
  • 2282032
  • 2282028

NDC Crossover Matching brand name "Sarclisa" or generic name "Isatuximab"

NDC	Brand Name	Generic Name
0024-0654	Sarclisa	isatuximab
0024-0656	Sarclisa	isatuximab