Briviact Injection, Suspension
NDC Package 50474-970-75

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

Package Information

Briviact (brivaracetam) injection is brivaracetam is used to treat seizures (epilepsy). This formulation utilizes a injection, suspension delivery system. Marketed by Ucb, Inc., this product is identified by NDC 50474-970 and is authorized under FDA application NDA205837.

Identification & Billing

NDC Package Code
50474-970-75
Package Description
10 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS (50474-970-63)
Product Code
50474-970
11-Digit Billing Format
50474097075
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Briviact
Non-Proprietary Name
Brivaracetam
Substance Name
Brivaracetam
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
BRIVARACETAM 50 mg/5mL
Pharmacologic Class
Epoxide Hydrolase Inhibitors - [MoA] (Mechanism of Action)
Usage Information
Brivaracetam is used to treat seizures (epilepsy).
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Ucb, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA205837
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-12-2016
Listing Expiration
12-31-2027
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 50474-970-75 identifies a specific commercial package of 10 vial, glass in 1 carton / 5 ml in 1 vial, glass (50474-970-63) of Briviact, a human prescription drug labeled by Ucb, Inc.. This injection, suspension is formulated for intravenous 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, Inc. on May 12, 2016. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Brivaracetam is used to treat seizures (epilepsy).

How is this Ucb, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50474097075. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
50474-970-75
11-Digit CMS (5-4-2)
50474-0970-75

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