Lamotrigine Tablet
NDC Package 62332-038-71

11-digit billing NDC: 62332003871
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Lamotrigine 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)].  . This formulation utilizes a tablet delivery system. Marketed by Alembic Pharmaceuticals Inc., this product is identified by NDC 62332-038 and is authorized under FDA application ANDA090607.

Identification & Billing

NDC Package Code
62332-038-71
Package Description
500 TABLET in 1 BOTTLE
Product Code
62332-038
11-Digit Billing Format
62332003871
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lamotrigine
Non-Proprietary Name
Lamotrigine
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 100 mg/1
Pharmacologic Class
Usage Information
Lamotrigine 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
Alembic Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090607
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-05-2018
Listing Expiration
12-31-2027
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 (62332-038). Click a package code to view its specific billing and regulatory data.

62332-038-30
30 TABLET in 1 BOTTLE
62332-038-31
100 TABLET in 1 BOTTLE
62332-038-91
1000 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 62332-038-71 identifies a specific commercial package of 500 tablet in 1 bottle of Lamotrigine, a human prescription drug labeled by Alembic Pharmaceuticals Inc.. 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 Alembic Pharmaceuticals Inc. on February 05, 2018. The current certification is valid through December 31, 2027.

How is this Alembic Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62332003871. 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)
62332-038-71
11-Digit CMS (5-4-2)
62332-0038-71

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