Leflunomide Tablet, Film Coated
NDC Package 70748-129-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Leflunomide tablets is a medication used to treat rheumatoid arthritis, a condition in which the body's defense system (immune system) fails to recognize the body as itself and attacks the healthy tissues around the joints. This formulation utilizes a tablet, film coated delivery system. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 70748-129 and is authorized under FDA application ANDA211863.

Identification & Billing

NDC Package Code
70748-129-06
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
70748-129
11-Digit Billing Format
70748012906
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Leflunomide
Non-Proprietary Name
Leflunomide
Substance Name
Leflunomide
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)
LEFLUNOMIDE 10 mg/1
Pharmacologic Class
Antirheumatic Agent - [EPC] (Established Pharmacologic Class)
Usage Information
This medication is used to treat rheumatoid arthritis, a condition in which the body's defense system (immune system) fails to recognize the body as itself and attacks the healthy tissues around the joints. Leflunomide helps to reduce the joint damage/pain/swelling and helps you to move better. It works by weakening your immune system and decreasing swelling (inflammation).

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211863
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-31-2020
Listing Expiration
12-31-2026
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 70748-129-06 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Leflunomide, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral use and contains leflunomide 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 Lupin Pharmaceuticals, Inc. on August 31, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat rheumatoid arthritis, a condition in which the body's defense system (immune system) fails to recognize the body as itself and attacks the healthy tissues around the joints. Leflunomide helps to reduce the joint damage/pain/swelling and helps you to move better. It works by weakening your immune system and decreasing swelling (inflammation).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70748012906. 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)
70748-129-06
11-Digit CMS (5-4-2)
70748-0129-06

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