Prescription drug · BLA
Elitek (Rasburicase) NDC 0024-5150
Kit · Sanofi-Aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0024-5150-10 | 0002451501000024515010 | 3 KIT in 1 CARTON (0024-5150-10) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, SINGLE-USE (0024-5154-11) * 1 mL in 1 AMPULE (0024-5152-11)Marketed from Jul 12, 2002 |
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)
- Elitek
- Generic name (nonproprietary)
- rasburicase
- Dosage form
- Kit
- Labeler
- Sanofi-Aventis U.S. LLCNDC labeler code 0024
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103946
- Marketing start
- Listing expires
- Identifiers
- Product ID 0024-5150_424aedac-a777-40a3-b6d3-a8fe7e305b79SPL ID 424aedac-a777-40a3-b6d3-a8fe7e305b79SPL set ID 0ae10bc4-6b65-402f-9db5-2d7753054922RxCUI 1790344, 1790347, 1790349, 1790351
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.
- NDC on a medical claim
N400024515010followed by a unit qualifier and the quantityPackage 00024-5150-10. 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)
Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Elitek is a recombinant urate-oxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ( 1 ) Limitations of use: Elitek is indicated only for a single course of treatment. ( 1 ) Limitations of Use Elitek is in…
Excerpt only. Read the full label for complete information.
About NDC 0024-5150
- What is NDC 0024-5150?
- 0024-5150 is the product NDC for Elitek (rasburicase) kit, 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?
- Elitek (Rasburicase).
- 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 Elitek?
- 1 other product NDC are listed under this name. See all Elitek NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Elitek products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Elitekrasburicase | — | Kit | Sanofi-Aventis U.S. LLC | 0024-5151 | 00024-5151-75 |
Other NDCs under BLA 103946
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 |
|---|---|---|---|---|
| Elitekrasburicase | — | Kit | Sanofi-Aventis U.S. LLC | 0024-5151 |