Fingolimod Powder
NDC Package 65035-201-01

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

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 powders is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a powder delivery system. Marketed by Everlight Chemical Industrial Corporation Kuanyin Ii Plant, this product is identified by NDC 65035-201.

Identification & Billing

NDC Package Code
65035-201-01
Package Description
1 g in 1 VIAL, GLASS
Product Code
65035-201
11-Digit Billing Format
65035020101

Clinical Specifications

Proprietary Name
Fingolimod
Non-Proprietary Name
Fingolimod
Substance Name
Fingolimod
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 1 g/g

Regulatory & Marketing

Labeler Name
Everlight Chemical Industrial Corporation Kuanyin Ii Plant
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-01-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65035-201). Click a package code to view its specific billing and regulatory data.

65035-201-05
5 g in 1 VIAL, GLASS
65035-201-10
10 g in 1 VIAL, GLASS
65035-201-50
50 g in 1 VIAL, GLASS

* 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 65035-201-01 identifies a specific commercial package of 1 g in 1 vial, glass of Fingolimod (UNFINISHED drug), a bulk ingredient labeled by Everlight Chemical Industrial Corporation Kuanyin Ii Plant. This powder is formulated for use and contains fingolimod 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 Everlight Chemical Industrial Corporation Kuanyin Ii Plant on December 01, 2011. The current certification is valid through December 31, 2026.

How is this Everlight Chemical Industrial Corporation Kuanyin Ii Plant product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65035020101. 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)
65035-201-01
11-Digit CMS (5-4-2)
65035-0201-01

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