Sandimmune Injection
NDC Package 0078-0109-01

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

Sandimmune (cyclosporine) injection is cyclosporine is used to prevent organ rejection in people who have received a liver, kidney, or heart transplant. This formulation utilizes a injection delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0109 and is authorized under FDA application NDA050573.

Identification & Billing

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
11-Digit Billing Format
00078010901
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sandimmune
Non-Proprietary Name
Cyclosporine
Substance Name
Cyclosporine
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CYCLOSPORINE 50 mg/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA050573
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-14-1983
Listing Expiration
12-31-2027
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.

J7516
Source: ASP
Inj, cyclosporine 250mg
HCPCS Dosage 250 MG
Units / Pkg 10

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 0078-0109-01 identifies a specific commercial 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. This injection is formulated for intravenous use and contains cyclosporine 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 November 14, 1983. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078010901. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0078-0109-01
11-Digit CMS (5-4-2)
00078-0109-01

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