Fingolimod Hcl Powder
NDC Package 84644-043-00

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 powders is a medication used to treat multiple sclerosis-MS. This formulation utilizes a powder delivery system. Marketed by Tapi Czech Industries S.r.o., this product is identified by NDC 84644-043.

Identification & Billing

NDC Package Code
84644-043-00
Package Description
1 kg in 1 CARTON
Product Code
84644-043
11-Digit Billing Format
84644004300

Clinical Specifications

Proprietary Name
Fingolimod Hcl
Non-Proprietary Name
Fingolimod Hcl
Substance Name
Fingolimod Hydrochloride
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
FINGOLIMOD HYDROCHLORIDE 100 kg/100kg
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
Tapi Czech Industries S.r.o.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-22-2013
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 84644-043-00 identifies a specific commercial package of 1 kg in 1 carton of Fingolimod Hcl (UNFINISHED drug), a bulk ingredient labeled by Tapi Czech Industries S.r.o.. This powder 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 Tapi Czech Industries S.r.o. on January 22, 2013. 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 Tapi Czech Industries S.r.o. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84644004300. 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 (5-3-2)
84644-043-00
11-Digit CMS (5-4-2)
84644-0043-00

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