Prescription drug · BLA
Kevzara (Sarilumab) NDC 0024-5920
Sarilumab 150 mg/1.14mL · Injection, Solution · Subcutaneous · Sanofi-Aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0024-5920-01 | 00024592001 | 2 SYRINGE in 1 PACKAGE (0024-5920-01) / 1.14 mL in 1 SYRINGE (0024-5920-00)Marketed from Apr 13, 2018 | |
| 0024-5920-02 | 00024592002 | 2 SYRINGE in 1 PACKAGE (0024-5920-02) / 1.14 mL in 1 SYRINGEMarketed from Apr 13, 2018 |
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)
- Kevzara
- Generic name (nonproprietary)
- sarilumab
- Active ingredients
- Sarilumab — 150 mg/1.14mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Sanofi-Aventis U.S. LLCNDC labeler code 0024
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761037
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin 6 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0024-5920_b1eeca31-be2b-4c68-a7c0-220256a2b906SPL ID b1eeca31-be2b-4c68-a7c0-220256a2b906SPL set ID 827bc01c-d379-4266-a18c-c7f904b76af3RxCUI 1923333, 1923338, 1923345, 1923347, 2003755, 2003757, 2003766, 2003767UNII NU90V55F8I
- Pharmacologic class
- Interleukin-6 Receptor Antagonist
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
N400024592001followed by a unit qualifier and the quantityPackage 00024-5920-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
KEVZARA ® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). ( 1.1 ) adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. ( 1.2 ) patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). ( 1.3 ) 1.1 Rheumatoid Arthritis (RA) KEVZARA ® is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have ha…
Excerpt only. Read the full label for complete information.
About NDC 0024-5920
- What is NDC 0024-5920?
- 0024-5920 is the product NDC for Kevzara (sarilumab), Sarilumab 150 mg/1.14mL injection, solution, listed with the FDA by Sanofi-Aventis U.S. LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kevzara (Sarilumab).
- What is the active ingredient?
- Sarilumab.
- 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 Kevzara?
- 3 other product NDCs are listed under this name. See all Kevzara NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kevzara products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kevzarasarilumab | Sarilumab 150 mg/1.14mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5908 | 00024-5908-0100024-5908-02 |
| Kevzarasarilumab | Sarilumab 200 mg/1.14mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5910 | 00024-5910-0100024-5910-02 |
| Kevzarasarilumab | Sarilumab 200 mg/1.14mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5922 | 00024-5922-0100024-5922-02 |
Other NDCs under BLA 761037
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 |
|---|---|---|---|---|
| Kevzarasarilumab | Sarilumab 150 mg/1.14mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5908 |
| Kevzarasarilumab | Sarilumab 200 mg/1.14mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5910 |
| Kevzarasarilumab | Sarilumab 200 mg/1.14mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5922 |