Lamotrigine Extended Release
NDC Package 49884-563-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Lamotrigine Extended Release is lamotrigine extended-release is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning, Warnings and Precautions (5.1, 5.2)]. Marketed by Par Health Usa, Llc, this product is identified by NDC 49884-563 and is authorized under FDA application ANDA201791.

Identification & Billing

NDC Package Code
49884-563-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
49884-563
11-Digit Billing Format
49884056301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lamotrigine Extended Release
Dosage Form
-
Usage Information
Lamotrigine extended-release is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning, Warnings and Precautions (5.1, 5.2)].

Regulatory & Marketing

Labeler Name
Par Health Usa, Llc
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
03-31-2026
Listing Expiration
03-31-2026
Exclude Flag
D
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 (49884-563). Click a package code to view its specific billing and regulatory data.

49884-563-05
500 TABLET in 1 BOTTLE
49884-563-11
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 49884-563-01 identifies a specific commercial package of 100 tablet in 1 bottle of Lamotrigine Extended Release, labeled by Par Health Usa, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Par Health Usa, Llc on January 18, 2013. The current certification is valid through March 31, 2026.

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: 49884056301. 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)
49884-563-01
11-Digit CMS (5-4-2)
49884-0563-01

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