Felbatol Tablet
NDC Package 0037-0430-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Felbatol (felbamate) tablets is felbamate is used to treat severe seizures. This formulation utilizes a tablet delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 0037-0430 and is authorized under FDA application NDA020189.

Identification & Billing

NDC Package Code
0037-0430-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
0037-0430
11-Digit Billing Format
00037043001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Felbatol
Non-Proprietary Name
Felbamate
Substance Name
Felbamate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FELBAMATE 400 mg/1
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020189
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-29-1993
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0037-0430-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Felbatol, a human prescription drug labeled by Viatris Specialty Llc. This tablet is formulated for oral use and contains felbamate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Viatris Specialty Llc on July 29, 1993. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00037043001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0037-0430-01
11-Digit CMS (5-4-2)
00037-0430-01

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.