NDC Package 0781-5056-31 Leflunomide

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory .

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:

0781-5056-31

Package Description:

30 TABLET, FILM COATED in 1 BOTTLE

Product Code:

0781-5056

Proprietary 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:

00781505631

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 EA

Labeler Name:

Sandoz Inc

Sample Package:

FDA Application Number:

ANDA077087

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

09-13-2005

End Marketing Date:

12-31-2013

Listing Expiration Date:

12-31-2013

Exclude Flag:

Code Structure:

0781 - Sandoz Inc
- 0781-5056 - Leflunomide
  - 0781-5056-31 - 30 TABLET, FILM COATED in 1 BOTTLE

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 Code	Package Description
0781-5056-01	100 TABLET, FILM COATED in 1 BOTTLE
0781-5056-10	1000 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0781-5056-31?

The NDC Packaged Code 0781-5056-31 is assigned to a package of 30 tablet, film coated in 1 bottle of Leflunomide, labeled by Sandoz Inc. The product's dosage form is and is administered via form.

Is NDC 0781-5056 included in the NDC Directory?

The product was first marketed by Sandoz Inc on September 13, 2005 and its listing in the NDC Directory is set to expire on December 31, 2013 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0781-5056-31?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 0781-5056-31?

The 11-digit format is 00781505631. 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 4-4-2 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0781-5056-31	5-4-2	00781-5056-31

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