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  4. NDC Product Code: 52817-243 Lamotrigine Extended Release

NDC 52817-243 Lamotrigine Extended Release

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 52817-243?
  5. Lamotrigine Extended Release Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
52817-243
Proprietary Name:
Lamotrigine Extended Release
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Trupharma, Llc
Labeler Code:
52817
Product Label ID:
9e154d39-8437-4ea9-8c7c-3fbff6fd1ddf
Start Marketing Date: [9]
06-05-2017
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
ORANGE (C48331 - PEACH)
YELLOW (C48330)
BLUE (C48333)
Shape:
ROUND (C48348)
Size(s):
9 MM
10 MM
Imprint(s):
H008
H009
H012
H011
Score:
1

Product Packages

NDC Code 52817-243-30

Package Description: 30 TABLET in 1 BOTTLE

Price per Unit: $1.08478 per EA

Product Details

What is NDC 52817-243?

The NDC code 52817-243 is assigned by the FDA to the product Lamotrigine Extended Release which is product labeled by Trupharma, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 52817-243-30 30 tablet in 1 bottle . 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 Lamotrigine Extended Release?

Lamotrigine extended-release tablets are contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning, Warnings and Precautions ( 5.1, 5.3)] .

Which are Lamotrigine Extended Release UNII Codes?

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

Which are Lamotrigine Extended Release 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 Lamotrigine Extended Release?

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: 850087 - lamoTRIgine 100 MG 24HR Extended Release Oral Tablet
  • RxCUI: 850087 - 24 HR lamotrigine 100 MG Extended Release Oral Tablet
  • RxCUI: 850087 - lamotrigine 100 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 850091 - lamoTRIgine 50 MG 24HR Extended Release Oral Tablet
  • RxCUI: 850091 - 24 HR lamotrigine 50 MG Extended Release Oral Tablet

* 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 Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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] 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".