Teriflunomide Tablet, Film Coated
NDC Package 82249-112-30

11-digit billing NDC: 82249011230
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Teriflunomide tablets 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 adults. This formulation utilizes a tablet, film coated delivery system. Marketed by Civica Script Llc, this product is identified by NDC 82249-112 and is authorized under FDA application ANDA209598.

Identification & Billing

NDC Package Code
82249-112-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
82249-112
11-Digit Billing Format
82249011230

Clinical Specifications

Proprietary Name
Teriflunomide
Non-Proprietary Name
Teriflunomide
Substance Name
Teriflunomide
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TERIFLUNOMIDE 14 mg/1
Pharmacologic Class
Usage Information
Teriflunomide tablets 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 adults.

Regulatory & Marketing

Labeler Name
Civica Script Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209598
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-26-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82249-112-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Teriflunomide, a human prescription drug labeled by Civica Script Llc. This tablet, film coated is formulated for oral use and contains teriflunomide 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 Civica Script Llc on October 26, 2026. The current certification is valid through December 31, 2027.

How is this Civica Script Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82249011230. 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)
82249-112-30
11-Digit CMS (5-4-2)
82249-0112-30

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