NDC Package 0054-0425-23 Rufinamide

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0054-0425-23

Package Description:

120 TABLET, FILM COATED in 1 BOTTLE

Product Code:

0054-0425

Proprietary Name:

Rufinamide

Non-Proprietary Name:

Rufinamide

Substance Name:

Rufinamide

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.

11-Digit NDC Billing Format:

00054042523

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

120 EA

NDC to RxNorm Crosswalk:

RxCUI: 824295 - rufinamide 200 MG Oral Tablet

RxCUI: 824301 - rufinamide 400 MG Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Hikma Pharmaceuticals Usa Inc.

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.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

RUFINAMIDE 200 mg/1

Sample Package:

FDA Application Number:

ANDA204988

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

05-30-2021

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

0054 - Hikma Pharmaceuticals Usa Inc.
- 0054-0425 - Rufinamide
  - 0054-0425-23 - 120 TABLET, FILM COATED in 1 BOTTLE

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 disclaimer below.

Frequently Asked Questions

What is NDC 0054-0425-23?

The NDC Packaged Code 0054-0425-23 is assigned to a package of 120 tablet, film coated in 1 bottle of Rufinamide, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 0054-0425 included in the NDC Directory?

Yes, Rufinamide with product code 0054-0425 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on May 30, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0054-0425-23?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 120.

What is the 11-digit format for NDC 0054-0425-23?

The 11-digit format is 00054042523. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0054-0425-23	5-4-2	00054-0425-23

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