NDC Package 0781-5125-31 Lamotrigine

View Billable Units, 11-Digit Format, RxNorm

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:
0781-5125-31
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Lamotrigine
Usage Information:
Lamotrigine is used alone or with other medications to prevent and control seizures. It may also be used to help prevent the extreme mood swings of bipolar disorder in adults. Lamotrigine is known as an anticonvulsant or antiepileptic drug. It is thought to work by restoring the balance of certain natural substances in the brain. This drug is not approved for use in children younger than 2 years due to an increased risk of side effects (such as infections).
11-Digit NDC Billing Format:
00781512531
Labeler Name:
Sandoz Inc
Sample Package:
No
FDA Application Number:
ANDA078645
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
01-05-2010
End Marketing Date:
01-05-2010
Listing Expiration Date:
01-05-2010
Exclude Flag:
D
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
0781-5125-01100 TABLET in 1 BOTTLE
0781-5125-101000 TABLET in 1 BOTTLE
0781-5125-13100 TABLET in 1 BOTTLE
0781-5125-6060 TABLET in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0781-5125-31?

The NDC Packaged Code 0781-5125-31 is assigned to a package of 30 tablet in 1 bottle of Lamotrigine, labeled by Sandoz Inc. The product's dosage form is and is administered via form.

Is NDC 0781-5125 included in the NDC Directory?

The product was first marketed by Sandoz Inc on January 05, 2010 and its listing in the NDC Directory is set to expire on January 05, 2010 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0781-5125-31?

The 11-digit format is 00781512531. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20781-5125-315-4-200781-5125-31