Sarclisa (isatuximab) NDC 0024-0654

NDC codes

FDA NDC Directory

Product NDC (as listed)0024-0654Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00024-0654Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0024-0654-01	00024065401	1 VIAL, SINGLE-DOSE in 1 CARTON (0024-0654-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 2, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Sarclisa
Generic name (nonproprietary): isatuximab
Active ingredients: Isatuximab — 100 mg/5mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Sanofi-Aventis U.S. LLC
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761113
Marketing start: Mar 2, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Monoclonal (Chemical structure)CD38-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 0024-0654_7bfd2975-f348-4a3b-890e-63006967b82aSPL ID 7bfd2975-f348-4a3b-890e-63006967b82aSPL set ID a0473462-6f9d-4eca-a5bf-8620aea68e8aRxCUI 2282023, 2282028, 2282031, 2282032UNII R30772KCU0
Pharmacologic class: CD38-directed Cytolytic Antibody

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400024065401 followed by a unit qualifier and the quantity

Package 00024-0654-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 7, 2026.

Indications (excerpt from the label)

SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). SARCLISA is a CD38-directed cytolytic antibody indicated: in combination with pomalido…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761113

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761113
Product	Strength	Form · route	Labeler	Product NDC
Sarclisaisatuximab	Isatuximab 500 mg/25mL	Injection, Solution, ConcentrateIntravenous	Sanofi-Aventis U.S. LLC	0024-0656