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  5. NDC Package Code: 0078-0331-84 Simulect

NDC Package 0078-0331-84 Simulect

Basiliximab Injection, Powder, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Simulect
Non-Proprietary Name:
Basiliximab
Substance Name:
Basiliximab
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).
11-Digit NDC Billing Format:
00078033184
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1656643 - basiliximab 10 MG Injection
  • RxCUI: 1656646 - Simulect 10 MG Injection
  • RxCUI: 1656646 - basiliximab 10 MG Injection [Simulect]
  • RxCUI: 1656648 - basiliximab 20 MG Injection
  • RxCUI: 1656650 - Simulect 20 MG Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    Dosage Form:
    Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • BASILIXIMAB 20 mg/5mL
    • Pharmacologic Class(es):
  • Interleukin 2 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Interleukin 2 Receptor-directed Antibody Interactions - [MoA] (Mechanism of Action)
  • Interleukin-2 Receptor Blocking Antibody - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA103764
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    05-12-1998
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0078-0331-84 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00078033184J0480Basiliximab20 MG1111

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0078-0331-84?

    The NDC Packaged Code 0078-0331-84 is assigned to a 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. The product's dosage form is injection, powder, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 0078-0331 included in the NDC Directory?

    Yes, Simulect with product code 0078-0331 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on May 12, 1998 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0078-0331-84?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0078-0331-84?

    The 11-digit format is 00078033184. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20078-0331-845-4-200078-0331-84