NDC Package 0078-0607-89 Gilenya

Fingolimod Hcl Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

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:
0078-0607-89
Package Description:
7 CAPSULE in 1 CARTON
Product Code:
Proprietary Name:
Gilenya
Non-Proprietary Name:
Fingolimod Hcl
Substance Name:
Fingolimod Hydrochloride
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.
11-Digit NDC Billing Format:
00078060789
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
7 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1012895 - fingolimod 0.5 MG Oral Capsule
  • RxCUI: 1012895 - fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule
  • RxCUI: 1012895 - fingolimod 500 MCG Oral Capsule
  • RxCUI: 1012899 - Gilenya 0.5 MG Oral Capsule
  • RxCUI: 1012899 - fingolimod 0.5 MG Oral Capsule [Gilenya]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA022527
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-21-2010
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0078-0607-1530 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0078-0607-89?

    The NDC Packaged Code 0078-0607-89 is assigned to a package of 7 capsule in 1 carton of Gilenya, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is capsule and is administered via oral form.

    Is NDC 0078-0607 included in the NDC Directory?

    Yes, Gilenya with product code 0078-0607 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on September 21, 2010 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 0078-0607-89?

    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 7.

    What is the 11-digit format for NDC 0078-0607-89?

    The 11-digit format is 00078060789. 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
    4-4-20078-0607-895-4-200078-0607-89