Lamotrigine Tablet, Orally Disintegrating
NDC Package 59917-080-00

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Lamotrigine tablets is lamotrigine is used alone or with other medications to prevent and control seizures. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Adare Pharmaceuticals Inc, this product is identified by NDC 59917-080.

Identification & Billing

NDC Package Code
59917-080-00
Package Description
18800 TABLET, ORALLY DISINTEGRATING in 1 DRUM
Product Code
59917-080
11-Digit Billing Format
59917008000

Clinical Specifications

Proprietary Name
Lamotrigine
Non-Proprietary Name
Lamotrigine
Substance Name
Lamotrigine
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Active Ingredient(s)
LAMOTRIGINE 200 mg/1
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).

Regulatory & Marketing

Labeler Name
Adare Pharmaceuticals Inc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
09-25-2008
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 59917-080-00 identifies a specific commercial package of 18800 tablet, orally disintegrating in 1 drum of Lamotrigine (UNFINISHED drug), drug for further processing labeled by Adare Pharmaceuticals Inc. This tablet, orally disintegrating is formulated for use and contains lamotrigine 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 Adare Pharmaceuticals Inc on September 25, 2008. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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).

How is this Adare Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59917008000. 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)
59917-080-00
11-Digit CMS (5-4-2)
59917-0080-00

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