Lamotrigine Tablet, Orally Disintegrating
NDC Package 0115-9939-01

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

Package Information

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 Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 0115-9939 and is authorized under FDA application ANDA200828.

Identification & Billing

NDC Package Code
0115-9939-01
Package Description
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code
0115-9939
11-Digit Billing Format
00115993901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LAMOTRIGINE 25 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
Amneal Pharmaceuticals Of New York Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA200828
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-27-2018
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0115-9939-01 identifies a specific commercial package of 30 tablet, orally disintegrating in 1 bottle of Lamotrigine, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. This tablet, orally disintegrating 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 Amneal Pharmaceuticals Of New York Llc on December 27, 2018. 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 Amneal Pharmaceuticals Of New York Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00115993901. 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 (4-4-2)
0115-9939-01
11-Digit CMS (5-4-2)
00115-9939-01

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