Lamotrigine Tablet, Orally Disintegrating
NDC Package 13668-693-72

11-digit billing NDC: 13668069372
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Lamotrigine tablets is adjunctive TherapyLamotrigine orally disintegrating 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 orally disintegrating 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 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, orally disintegrating delivery system. Marketed by Torrent Pharmaceuticals Limited, this product is identified by NDC 13668-693 and is authorized under FDA application ANDA217100.

Identification & Billing

NDC Package Code
13668-693-72
Package Description
30 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (13668-693-71)
Product Code
13668-693
11-Digit Billing Format
13668069372
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
Adjunctive TherapyLamotrigine orally disintegrating 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 orally disintegrating 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 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
Torrent Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217100
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-08-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (13668-693). Click a package code to view its specific billing and regulatory data.

13668-693-01
100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
13668-693-30
30 TABLET, ORALLY DISINTEGRATING 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 13668-693-72 identifies a specific commercial package of 30 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack (13668-693-71) of Lamotrigine, a human prescription drug labeled by Torrent Pharmaceuticals Limited. 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 Torrent Pharmaceuticals Limited on January 08, 2026. The current certification is valid through December 31, 2027.

How is this Torrent Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13668069372. 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)
13668-693-72
11-Digit CMS (5-4-2)
13668-0693-72

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