Gilenya Capsule
NDC Package 0078-0607-89

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

Package Information

Gilenya (fingolimod hcl) capsules is a medication used to treat multiple sclerosis-MS. This formulation utilizes a capsule delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0607 and is authorized under FDA application NDA022527.

Identification & Billing

NDC Package Code
0078-0607-89
Package Description
7 CAPSULE in 1 CARTON
Product Code
0078-0607
11-Digit Billing Format
00078060789
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
7 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gilenya
Non-Proprietary Name
Fingolimod Hcl
Substance Name
Fingolimod Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FINGOLIMOD HYDROCHLORIDE .5 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat multiple sclerosis-MS. It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA022527
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-21-2010
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0078-0607). Click a package code to view its specific billing and regulatory data.

0078-0607-15
30 CAPSULE in 1 BOTTLE
0078-0607-51
28 CAPSULE in 1 CARTON

* 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 0078-0607-89 identifies a specific commercial package of 7 capsule in 1 carton of Gilenya, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This capsule is formulated for oral use and contains fingolimod hydrochloride 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 September 21, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat multiple sclerosis-MS. It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078060789. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 7 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)
0078-0607-89
11-Digit CMS (5-4-2)
00078-0607-89

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