Fingolimod Capsule
NDC Package 68462-166-07

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

Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. This formulation utilizes a capsule delivery system. Marketed by Glenmark Pharmaceuticals Inc., Usa, this product is identified by NDC 68462-166 and is authorized under FDA application ANDA207985.

Identification & Billing

NDC Package Code
68462-166-07
Package Description
7 BLISTER PACK in 1 CARTON / 7 CAPSULE in 1 BLISTER PACK
Product Code
68462-166
11-Digit Billing Format
68462016607
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fingolimod
Non-Proprietary Name
Fingolimod
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
Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.

Regulatory & Marketing

Labeler Name
Glenmark Pharmaceuticals Inc., Usa
Product Type
Human Prescription Drug
FDA Application #
ANDA207985
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-28-2022
Listing Expiration
12-31-2027
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 (68462-166). Click a package code to view its specific billing and regulatory data.

68462-166-15
28 CARTON in 1 CARTON / 14 BLISTER PACK in 1 CARTON (68462-166-41) / 14 CAPSULE in 1 BLISTER PACK
68462-166-30
30 CAPSULE in 1 BOTTLE

* 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 68462-166-07 identifies a specific commercial package of 7 blister pack in 1 carton / 7 capsule in 1 blister pack of Fingolimod, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. 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 Glenmark Pharmaceuticals Inc., Usa on September 28, 2022. The current certification is valid through December 31, 2027.

How is this Glenmark Pharmaceuticals Inc., Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68462016607. 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)
68462-166-07
11-Digit CMS (5-4-2)
68462-0166-07

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