Rufinamide Tablet, Film Coated
NDC Package 51148-009-01

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.

Rufinamide tablets is rufinamide is used with other medications to prevent or control seizures (epilepsy) associated with Lennox-Gastaut syndrome (LGS). This formulation utilizes a tablet, film coated delivery system. Marketed by Bushu Pharmaceuticals, Ltd., this product is identified by NDC 51148-009.

Identification & Billing

NDC Package Code
51148-009-01
Package Description
1 BAG in 1 DRUM / 40000 TABLET, FILM COATED in 1 BAG
Product Code
51148-009
11-Digit Billing Format
51148000901

Clinical Specifications

Proprietary Name
Rufinamide
Non-Proprietary Name
Rufinamide
Substance Name
Rufinamide
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)
RUFINAMIDE 200 mg/1
Usage Information
Rufinamide is used with other medications to prevent or control seizures (epilepsy) associated with Lennox-Gastaut syndrome (LGS). This medication is an anticonvulsant. Rufinamide is thought to work by acting on the sodium channels in the brain that carry excessive electrical charges that may cause seizures.

Regulatory & Marketing

Labeler Name
Bushu Pharmaceuticals, Ltd.
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
11-14-2008
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 51148-009-01 identifies a specific commercial package of 1 bag in 1 drum / 40000 tablet, film coated in 1 bag of Rufinamide (UNFINISHED drug), drug for further processing labeled by Bushu Pharmaceuticals, Ltd.. This tablet, film coated is formulated for use and contains rufinamide 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 Bushu Pharmaceuticals, Ltd. on November 14, 2008. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Rufinamide is used with other medications to prevent or control seizures (epilepsy) associated with Lennox-Gastaut syndrome (LGS). This medication is an anticonvulsant. Rufinamide is thought to work by acting on the sodium channels in the brain that carry excessive electrical charges that may cause seizures.

How is this Bushu Pharmaceuticals, Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51148000901. 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)
51148-009-01
11-Digit CMS (5-4-2)
51148-0009-01

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