Simulect Injection, Powder, For Solution
NDC Package 0078-0331-84

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Simulect (basiliximab) injection is basiliximab is used to prevent organ rejection in people who have received a kidney transplant. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0331 and is authorized under FDA application BLA103764.

Identification & Billing

NDC Package Code
0078-0331-84
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE
Product Code
0078-0331
11-Digit Billing Format
00078033184
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Simulect
Non-Proprietary Name
Basiliximab
Substance Name
Basiliximab
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
BASILIXIMAB 20 mg/5mL
Pharmacologic Class
Usage Information
Basiliximab is used to prevent organ rejection in people who have received a kidney transplant. It is usually taken along with other medications (e.g., cyclosporine, corticosteroids) to allow your new organ to function normally. Basiliximab is an immunosuppressant drug known as a monoclonal antibody. It works by slowing down your body's defense system (immune system) to prevent your body from rejecting the new kidney after surgery (acute rejection).

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
BLA103764
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-12-1998
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0480
Source: PDAC
INJECTION, BASILIXIMAB, 20 MG
HCPCS Dosage 20 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0078-0331-84 identifies a specific commercial package of 1 vial, single-use in 1 carton / 5 ml in 1 vial, single-use of Simulect, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, for solution is formulated for intravenous use and contains basiliximab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novartis Pharmaceuticals Corporation on May 12, 1998. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Basiliximab is used to prevent organ rejection in people who have received a kidney transplant. It is usually taken along with other medications (e.g., cyclosporine, corticosteroids) to allow your new organ to function normally. Basiliximab is an immunosuppressant drug known as a monoclonal antibody. It works by slowing down your body's defense system (immune system) to prevent your body from rejecting the new kidney after surgery (acute rejection).

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078033184. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0078-0331-84
11-Digit CMS (5-4-2)
00078-0331-84

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.