Fingolimod Hcl Capsule
NDC Package 17088-0219-1

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Fingolimod Hcl capsules is a medication used to treat multiple sclerosis-MS. This formulation utilizes a capsule delivery system. Marketed by Novartis Pharma Stein Ag, this product is identified by NDC 17088-0219.

Identification & Billing

NDC Package Code
17088-0219-1
Package Description
25000 CAPSULE in 1 DRUM
Product Code
17088-0219
11-Digit Billing Format
17088021901

Clinical Specifications

Proprietary Name
Fingolimod Hcl
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.
Active Ingredient(s)
FINGOLIMOD HYDROCHLORIDE .5 mg/1
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 Pharma Stein Ag
Product Type
Human Prescription Drug
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
09-21-2010
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 17088-0219-1 identifies a specific commercial package of 25000 capsule in 1 drum of Fingolimod Hcl (UNFINISHED drug), a human prescription drug labeled by Novartis Pharma Stein Ag. This capsule is formulated for 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 Pharma Stein Ag 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 Pharma Stein Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17088021901. 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 (5-4-1)
17088-0219-1
11-Digit CMS (5-4-2)
17088-0219-01

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