NDC 0131-2479-99 Vimpat

Lacosamide

NDC Package Code 0131-2479-99

The NDC Code 0131-2479-99 is assigned to a package of 1 blister pack in 1 carton > 14 tablet, film coated in 1 blister pack of Vimpat, a human prescription drug labeled by Ucb, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Field Name Field Value
NDC Code 0131-2479-99
Package Description 1 BLISTER PACK in 1 CARTON > 14 TABLET, FILM COATED in 1 BLISTER PACK
Proprietary Name Vimpat 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.
Non-Proprietary Name Lacosamide 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.
Drug Uses Lacosamide is used to prevent and control seizures. It is an anticonvulsant or antiepileptic drug. It works by reducing the spread of seizure activity in the brain.
11-Digit NDC Billing Format 00131247999 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
RxNorm Crosswalk809974, 809984, 809987, 809990, 809992, 809994, 809996, 809998, 810000, 810002, 881271, 881272, 993856 and 995156 - RxCUIs What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type Human Prescription Drug 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.
Labeler Name Ucb, Inc.
Dosage Form Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • LACOSAMIDE 150 mg/1
Pharmacological Class(es)
  • Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
DEA Schedule Schedule V (CV) Substances What is the Drug Enforcement Administration (DEA) CV Schedule?
The controlled substances in the CV schedule have an abuse potential and dependence liability less than those listed in CIV and have an accepted medical use in the United States. Substances in schedule CV are often available without prescription, and include preparations containing limited quantities of certain narcotic drugs generally for antitussive and antidiarrheal purposes. Buprenorphine is also a CV schedule drug.
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. 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.
FDA Application Number NDA022253 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.
Start Marketing Date 05-26-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 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.
Exclude Flag N 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".

NDC Code Structure

  • 0131 - Ucb, Inc.
    • 0131-2479 - Vimpat
      • 0131-2479-99 - 1 BLISTER PACK in 1 CARTON

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 Vimpat with product NDC 0131-2479.

NDC Package CodePackage Description
0131-2479-3560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
0131-2479-606 BLISTER PACK in 1 CARTON > 10 TABLET, FILM COATED in 1 BLISTER PACK

* Please review the disclaimer below.