Felbatol
NDC 0037-0442

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0037-0442?
  5. Felbatol Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Felbatol is a NDA-approved product labeled by Viatris Specialty Llc. Felbamate is used to treat severe seizures. It is supplied as a yellow product. This product entry covers the primary NDC 0037-0442 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0037-0442
Proprietary Name:
Felbatol
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Viatris Specialty Llc
Labeler Code:
0037
Product Label ID:
2f522701-397a-11de-8a39-0800200c9a66
FDA Application Number: [6]
NDA020189
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
07-29-1993
End Marketing Date: [10]
11-30-2025
Listing Expiration Date: [11]
11-30-2025
Exclude Flag: [12]
D

Product Characteristics

Color(s):
YELLOW (C48330)
ORANGE (C48331 - PEACH)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
19 MM
Imprint(s):
0430
0431
Score:
2

Code Structure Chart

Product Details

What is NDC 0037-0442?

The NDC code 0037-0442 is assigned by the FDA to the product Felbatol. This pharmaceutical product is labeled by Viatris Specialty Llc and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 0037-0442-17, 0037-0442-67. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Felbamate is used to treat severe seizures. This medication should be used only when you cannot take other medications or when other medications have not been able to control your seizures. Felbamate is known as an anticonvulsant or anti-epileptic drug.

Which are the associated UNII Codes?

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

What is the NDC to RxNorm Crosswalk for this product?

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:

* Please review the full disclaimer at the bottom of this page.

Patient Education

Felbamate


Felbamate is used to treat certain seizures in adults and children with epilepsy whose seizures have not improved with other treatments. It is used alone or in combination with other medications to treat partial seizures in adults. It is used in combination with other medications to treat partial and generalized seizures in children with Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Felbamate is in a class of medications called anticonvulsants. It works by decreasing abnormal activity in the brain.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This 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.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".