Drug Information

Product NDC: 0378-4252

Proprietary Name: Lamotrigine

Non Proprietary Name: lamotrigine

Active Ingredient(s):
  • 100 mg/1 LAMOTRIGINE

Administration Route(s): ORAL

Dosage Form(s): TABLET

Pharmacy Class(es):
  • Decreased Central Nervous System Disorganized Electrical Activity [PE];
  • Mood Stabilizer [EPC];
  • Anti-epileptic Agent [EPC]

Labeler Information

Labeler Name: Mylan Pharmaceuticals Inc.
FDA Application Number: ANDA077420
Marketing Category: ANDA
Start Marketing Date:1/27/2009
End Marketing Date:4/30/2020

Package Information

No. Package Code Package Description Billing Unit
10378-4252-01100 TABLET in 1 BOTTLE, PLASTIC (0378-4252-01)EA
20378-4252-05500 TABLET in 1 BOTTLE, PLASTIC (0378-4252-05)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0378-4252The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMELamotrigineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMElamotrigineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/27/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE4/30/2020This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEANDAProduct 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.
APPLICATION NUMBERANDA077420This 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.
LABELER NAMEMylan Pharmaceuticals Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMELAMOTRIGINEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESDecreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC] 

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This page was last updated on: 10/4/2019