Lamotrigine Tablet
NDC Package 67046-0359-3

11-digit billing NDC: 67046035903
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lamotrigine tablets is adjunctive TherapyLamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:partial-onset seizures.primary generalized tonic-clonic (PGTC) seizures.generalized seizures of Lennox-Gastaut syndrome.MonotherapyLamotrigine tablets are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).Safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. This formulation utilizes a tablet delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-0359 and is authorized under FDA application ANDA090170.

Identification & Billing

NDC Package Code
67046-0359-3
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
67046-0359
11-Digit Billing Format
67046035903
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
Adjunctive TherapyLamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:partial-onset seizures.primary generalized tonic-clonic (PGTC) seizures.generalized seizures of Lennox-Gastaut syndrome.MonotherapyLamotrigine tablets are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).Safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.

Regulatory & Marketing

Labeler Name
Coupler Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090170
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-26-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67046-0359-3 identifies a specific commercial package of 30 tablet in 1 blister pack of Lamotrigine, a human prescription drug labeled by Coupler 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 Coupler Llc on May 26, 2026. The current certification is valid through December 31, 2027.

How is this Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046035903. 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 (5-4-1)
67046-0359-3
11-Digit CMS (5-4-2)
67046-0359-03

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