Lamotrigine Extended Release Tablet
NDC Package 49884-604-01

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Lamotrigine Extended Release tablets is lamotrigine is used alone or with other medications to prevent and control seizures. This formulation utilizes a tablet delivery system. Marketed by Par Health Usa, Llc, this product is identified by NDC 49884-604 and is authorized under FDA application ANDA201791.

Identification & Billing

NDC Package Code
49884-604-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
49884-604
11-Digit Billing Format
49884060401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lamotrigine Extended Release
Non-Proprietary Name
Lamotrigine Extended Release
Substance Name
Lamotrigine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LAMOTRIGINE 250 mg/1
Pharmacologic Class
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
Par Health Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA201791
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-18-2013
End Marketing Date
09-30-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49884-604). Click a package code to view its specific billing and regulatory data.

49884-604-05
500 TABLET in 1 BOTTLE
49884-604-11
30 TABLET in 1 BOTTLE

* 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 49884-604-01 identifies a specific commercial package of 100 tablet in 1 bottle of Lamotrigine Extended Release, a human prescription drug labeled by Par Health Usa, Llc. This tablet is formulated for oral 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 Par Health Usa, Llc on January 18, 2013.

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 Par Health Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49884060401. 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)
49884-604-01
11-Digit CMS (5-4-2)
49884-0604-01

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