Brivaracetam Tablet, Film Coated
NDC Package 36998-4100-0

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Brivaracetam tablets is brivaracetam is used to treat seizures (epilepsy). This formulation utilizes a tablet, film coated delivery system. Marketed by Ucb Pharma S.a., this product is identified by NDC 36998-4100.

Identification & Billing

NDC Package Code
36998-4100-0
Package Description
250000 TABLET, FILM COATED in 1 DRUM
Product Code
36998-4100
11-Digit Billing Format
36998410000

Clinical Specifications

Proprietary Name
Brivaracetam
Non-Proprietary Name
Brivaracetam
Substance Name
Brivaracetam
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.
Active Ingredient(s)
BRIVARACETAM 25 mg/1
Usage Information
Brivaracetam is used to treat seizures (epilepsy).
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Ucb Pharma S.a.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
05-12-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 36998-4100-0 identifies a specific commercial package of 250000 tablet, film coated in 1 drum of Brivaracetam (UNFINISHED drug), drug for further processing labeled by Ucb Pharma S.a.. This tablet, film coated is formulated for use and contains brivaracetam 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 Ucb Pharma S.a. on May 12, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Brivaracetam is used to treat seizures (epilepsy).

How is this Ucb Pharma S.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36998410000. 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 (5-4-1)
36998-4100-0
11-Digit CMS (5-4-2)
36998-4100-00

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