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  5. NDC Package Code: 42419-012-01 Lamotrigine

NDC Package 42419-012-01 Lamotrigine

Powder - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
42419-012-01
Package Description:
25 kg in 1 DRUM
Product Code:
42419-012
Non-Proprietary Name:
Lamotrigine
Substance Name:
Lamotrigine
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).
11-Digit NDC Billing Format:
42419001201
Product Type:
Bulk Ingredient
Labeler Name:
Ctx Lifesciences Pvt. Ltd.
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
  • LAMOTRIGINE 25 kg/25kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    04-14-2012
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    42419-012-0225 kg in 1 DRUM

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 42419-012-01?

    The NDC Packaged Code 42419-012-01 is assigned to an UNFINISHED drug package of 25 kg in 1 drum of Lamotrigine, a bulk ingredient labeled by Ctx Lifesciences Pvt. Ltd.. The product's dosage form is powder and is administered via form.

    Is NDC 42419-012 included in the NDC Directory?

    Yes, Lamotrigine is an UNFINISHED PRODUCT with code 42419-012 that is active and included in the NDC Directory. The product was first marketed by Ctx Lifesciences Pvt. Ltd. on April 14, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 42419-012-01?

    The 11-digit format is 42419001201. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-242419-012-015-4-242419-0012-01