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  5. NDC Package Code: 0078-0109-01 Sandimmune

NDC Package 0078-0109-01 Sandimmune

Cyclosporine Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0078-0109-01
Package Description:
10 AMPULE in 1 BOX / 5 mL in 1 AMPULE (0078-0109-61)
Product Code:
0078-0109
Proprietary Name:
Sandimmune
Non-Proprietary Name:
Cyclosporine
Substance Name:
Cyclosporine
Usage Information:
Cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. It is usually taken along with other medications to allow your new organ to function normally. Cyclosporine belongs to a class of drugs known as immunosuppressants. It works by weakening the immune system to help your body accept the new organ as if it were your own.
11-Digit NDC Billing Format:
00078010901
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 197552 - SandIMMUNE 100 MG Oral Capsule
  • RxCUI: 197552 - cyclosporine 100 MG Oral Capsule [Sandimmune]
  • RxCUI: 197552 - Sandimmune 100 MG Oral Capsule
  • RxCUI: 197553 - cycloSPORINE 25 MG Oral Capsule
  • RxCUI: 197553 - cyclosporine 25 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • CYCLOSPORINE 50 mg/mL
    • Pharmacologic Class(es):
  • Calcineurin Inhibitor Immunosuppressant - [EPC] (Established Pharmacologic Class)
  • Calcineurin Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA050573
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-14-1983
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 0078-0109-01?

    The NDC Packaged Code 0078-0109-01 is assigned to a package of 10 ampule in 1 box / 5 ml in 1 ampule (0078-0109-61) of Sandimmune, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 0078-0109 included in the NDC Directory?

    Yes, Sandimmune with product code 0078-0109 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on November 14, 1983 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0078-0109-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0078-0109-01?

    The 11-digit format is 00078010901. 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
    4-4-20078-0109-015-4-200078-0109-01