Lamotrigine Extended Release
NDC Package 52817-243-30

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Lamotrigine Extended Release is lamotrigine extended-release tablets are 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, 5.3)]. Marketed by Trupharma, Llc, this product is identified by NDC 52817-243 and is authorized under FDA application ANDA202887.

Identification & Billing

NDC Package Code
52817-243-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
52817-243
11-Digit Billing Format
52817024330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 850087 - lamoTRIgine 100 MG 24HR Extended Release Oral Tablet
  • RxCUI: 850087 - 24 HR lamotrigine 100 MG Extended Release Oral Tablet
  • RxCUI: 850087 - lamotrigine 100 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 850091 - lamoTRIgine 50 MG 24HR Extended Release Oral Tablet
  • RxCUI: 850091 - 24 HR lamotrigine 50 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Lamotrigine Extended Release
Dosage Form
-
Usage Information
Lamotrigine extended-release tablets are 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, 5.3)] .

Regulatory & Marketing

Labeler Name
Trupharma, Llc
FDA Application #
ANDA202887
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-05-2017
Listing Expiration
12-31-2022
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52817-243-30 identifies a specific commercial package of 30 tablet in 1 bottle of Lamotrigine Extended Release, labeled by Trupharma, 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 Trupharma, Llc on June 05, 2017. The current certification is valid through December 31, 2022.

How is this Trupharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52817024330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
52817-243-30
11-Digit CMS (5-4-2)
52817-0243-30

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