Fingolimod Capsule
NDC Package 70377-019-11

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 18 years of age and older.Pediatric use information is approved for Novartis Pharmaceuticals Corporation’s GILENYA (fingolimod) capsules. This formulation utilizes a capsule delivery system. Marketed by Biocon Pharma Inc., this product is identified by NDC 70377-019 and is authorized under FDA application ANDA207979.

Identification & Billing

NDC Package Code
70377-019-11
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
70377-019
11-Digit Billing Format
70377001911
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 18 years of age and older.Pediatric use information is approved for Novartis Pharmaceuticals Corporation’s GILENYA (fingolimod) capsules. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Regulatory & Marketing

Labeler Name
Biocon Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207979
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-28-2024
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 (70377-019). Click a package code to view its specific billing and regulatory data.

70377-019-21
28 CAPSULE in 1 CARTON

* 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 70377-019-11 identifies a specific commercial package of 30 capsule in 1 bottle of Fingolimod, a human prescription drug labeled by Biocon Pharma Inc.. 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 Biocon Pharma Inc. on March 28, 2024. The current certification is valid through December 31, 2027.

How is this Biocon Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70377001911. 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)
70377-019-11
11-Digit CMS (5-4-2)
70377-0019-11

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