Prescription drug · BLA
Simulect (Basiliximab) NDC 0078-0331
Basiliximab 20 mg/5mL · Injection, Powder, For solution · Intravenous · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0331-84 | 00078033184 | 1 VIAL, SINGLE-USE in 1 CARTON (0078-0331-84) / 5 mL in 1 VIAL, SINGLE-USEMarketed from May 12, 1998 |
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)
- Simulect
- Generic name (nonproprietary)
- basiliximab
- Active ingredients
- Basiliximab — 20 mg/5mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103764
- Marketing start
- Listing expires
- Other FDA classes
- Interleukin 2 Receptor Antagonists (Mechanism)Interleukin 2 Receptor-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 0078-0331_3a12b631-15b1-4b4a-a018-692037cc4709SPL ID 3a12b631-15b1-4b4a-a018-692037cc4709SPL set ID 1af01887-b69d-444b-91ed-ebfe12784440RxCUI 1656643, 1656646, 1656648, 1656650UNII 9927MT646M
- Pharmacologic class
- Interleukin-2 Receptor Blocking 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
N400078033184followed by a unit qualifier and the quantityPackage 00078-0331-84. 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)
INDICATIONS AND USAGE Simulect ® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.
Excerpt only. Read the full label for complete information.
About NDC 0078-0331
- What is NDC 0078-0331?
- 0078-0331 is the product NDC for Simulect (basiliximab), Basiliximab 20 mg/5mL injection, powder, for solution, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Simulect (Basiliximab).
- What is the active ingredient?
- Basiliximab.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Simulect?
- 1 other product NDC are listed under this name. See all Simulect NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Simulect products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Simulectbasiliximab | Basiliximab 10 mg/2.5mL | Injection, Powder, For solutionIntravenous | Novartis Pharmaceuticals Corporation | 0078-0393 | 00078-0393-61 |
Other NDCs under BLA 103764
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 |
|---|---|---|---|---|
| Simulectbasiliximab | Basiliximab 10 mg/2.5mL | Injection, Powder, For solutionIntravenous | Novartis Pharmaceuticals Corporation | 0078-0393 |