NDC 0173-0758 Lamictal XR
Lamotrigine Kit

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0173-0758?
    5. Lamictal XR Uses
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Patient Education

Product Information

NDC Product Code0173-0758
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Lamictal XR
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Lamotrigine
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormKit - A packaged collection of related material.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Glaxosmithkline Llc
Labeler Code0173
SPL SET ID:3e2c9a35-6a39-41d7-ad84-3c0bb8894b09
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		NDA022115
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		07-06-2009
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

Product Characteristics

Color(s)YELLOW (C48330 - WITH A WHITE CENTER)
GREEN (C48329 - WITH A WHITE CENTER)
ORANGE (C48331 - WITH A WHITE CENTER)
BLUE (C48333 - WITH A WHITE CENTER)
ShapeROUND (C48348)
Size(s)9 MM
10 MM
Imprint(s)LAMICTAL;XR;25
LAMICTAL;XR;50
LAMICTAL;XR;100
LAMICTAL;XR;200
Score1

Product Packages

NDC Code 0173-0758-00

Package Description: 1 BLISTER PACK in 1 PACKAGE, COMBINATION / 1 KIT in 1 BLISTER PACK

Product Details

What is NDC 0173-0758?

The NDC code 0173-0758 is assigned by the FDA to the product Lamictal XR which is a human prescription drug product labeled by Glaxosmithkline Llc. The generic name of Lamictal XR is lamotrigine. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0173-0758-00 1 blister pack in 1 package, combination / 1 kit in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Lamictal XR?

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).

Which are Lamictal XR UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Lamictal XR Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Lamictal XR?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1098608 - lamoTRIgine 300 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1098608 - 24 HR lamotrigine 300 MG Extended Release Oral Tablet
  • RxCUI: 1098608 - lamotrigine 300 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1098610 - LaMICtal XR 300 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1098610 - 24 HR lamotrigine 300 MG Extended Release Oral Tablet [Lamictal]

* Please review the disclaimer below.

Patient Education

Lamotrigine


Lamotrigine extended-release (long-acting) tablets are used with other medications to treat certain types of seizures in patients who have epilepsy. All types of lamotrigine tablets (tablets, orally disintegrating tablets, and chewable tablets) other than the extended-release tablets are used alone or with other medications to treat seizures in people who have epilepsy or Lennox-Gastaut syndrome (a disorder that causes seizures and often causes developmental delays). All types of lamotrigine tablets other than the extended-release tablets are also used to increase the time between episodes of depression, mania (frenzied or abnormally excited mood), and other abnormal moods in patients with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Lamotrigine has not been shown to be effective when people experience the actual episodes of depression or mania, so other medications must be used to help people recover from these episodes. Lamotrigine is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
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* Please review the disclaimer below.

Product Label

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