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  5. NDC Package Code: 0054-0528-63 Rufinamide

NDC Package 0054-0528-63 Rufinamide

Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0054-0528-63
Package Description:
1 BOTTLE in 1 CARTON / 460 mL in 1 BOTTLE
Product Code:
0054-0528
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:
00054052863
NDC to RxNorm Crosswalk:
  • RxCUI: 1092357 - rufinamide 40 MG in 1 mL Oral Suspension
  • RxCUI: 1092357 - rufinamide 40 MG/ML Oral Suspension
  • RxCUI: 1092357 - rufinamide 40 MG per 1 ML Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • RUFINAMIDE 40 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    ANDA207363
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-01-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 0054-0528-63?

    The NDC Packaged Code 0054-0528-63 is assigned to a package of 1 bottle in 1 carton / 460 ml in 1 bottle of Rufinamide, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is suspension and is administered via oral form.

    Is NDC 0054-0528 included in the NDC Directory?

    Yes, Rufinamide with product code 0054-0528 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on November 01, 2020 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 11-digit format for NDC 0054-0528-63?

    The 11-digit format is 00054052863. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20054-0528-635-4-200054-0528-63