Prescription drug · BLA
Sarclisa (Isatuximab) NDC 0024-0654
Isatuximab 100 mg/5mL · Injection, Solution, Concentrate · Intravenous · Sanofi-Aventis U.S. LLC
NDC codes
FDA NDC Directory| 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. LLCNDC labeler code 0024
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761113
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N400024065401followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 0024-0654
- What is NDC 0024-0654?
- 0024-0654 is the product NDC for Sarclisa (isatuximab), Isatuximab 100 mg/5mL injection, solution, concentrate, listed with the FDA by Sanofi-Aventis U.S. LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sarclisa (Isatuximab).
- What is the active ingredient?
- Isatuximab.
- Who is the labeler?
- Sanofi-Aventis U.S. LLC, NDC labeler code 0024. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sarclisa?
- 1 other product NDC are listed under this name. See all Sarclisa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sarclisa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sarclisaisatuximab | Isatuximab 500 mg/25mL | Injection, Solution, ConcentrateIntravenous | Sanofi-Aventis U.S. LLC | 0024-0656 | 00024-0656-01 |
Other NDCs under BLA 761113
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sarclisaisatuximab | Isatuximab 500 mg/25mL | Injection, Solution, ConcentrateIntravenous | Sanofi-Aventis U.S. LLC | 0024-0656 |