NDC Package 70771-1492-1 Leflunomide

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
70771-1492-1
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Leflunomide
Non-Proprietary Name:
Leflunomide
Substance Name:
Leflunomide
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).
11-Digit NDC Billing Format:
70771149201
NDC to RxNorm Crosswalk:
  • RxCUI: 205284 - leflunomide 10 MG Oral Tablet
  • RxCUI: 205285 - leflunomide 20 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Lifesciences Limited
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA212308
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-26-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70771-1492-330 TABLET, FILM COATED in 1 BOTTLE
    70771-1492-5500 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70771-1492-1?

    The NDC Packaged Code 70771-1492-1 is assigned to a package of 100 tablet, film coated in 1 bottle of Leflunomide, a human prescription drug labeled by Zydus Lifesciences Limited. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 70771-1492 included in the NDC Directory?

    Yes, Leflunomide with product code 70771-1492 is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on April 26, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70771-1492-1?

    The 11-digit format is 70771149201. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-170771-1492-15-4-270771-1492-01