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  5. NDC Package Code: 72578-057-16 Felbamate

NDC Package 72578-057-16 Felbamate

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
72578-057-16
Package Description:
90 TABLET in 1 BOTTLE
Product Code:
72578-057
Proprietary Name:
Felbamate
Non-Proprietary Name:
Felbamate
Substance Name:
Felbamate
Usage Information:
Felbamate is used to treat severe seizures. This medication should be used only when you cannot take other medications or when other medications have not been able to control your seizures. Felbamate is known as an anticonvulsant or anti-epileptic drug.
11-Digit NDC Billing Format:
72578005716
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 198358 - felbamate 400 MG Oral Tablet
  • RxCUI: 198358 - FELT 400 MG Oral Tablet
  • RxCUI: 198359 - felbamate 600 MG Oral Tablet
  • RxCUI: 198359 - FELT 600 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Viona Pharmaceuticals Inc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FELBAMATE 600 mg/1
    • Pharmacologic Class(es):
  • Anti-epileptic Agent - [EPC] (Established Pharmacologic Class)
  • Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA208970
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-03-2020
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    72578-057-01100 TABLET in 1 BOTTLE
    72578-057-05500 TABLET in 1 BOTTLE
    72578-057-0630 TABLET in 1 BOTTLE
    72578-057-28180 TABLET in 1 BOTTLE
    72578-057-7710 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (72578-057-30)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 72578-057-16?

    The NDC Packaged Code 72578-057-16 is assigned to a package of 90 tablet in 1 bottle of Felbamate, a human prescription drug labeled by Viona Pharmaceuticals Inc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 72578-057 included in the NDC Directory?

    Yes, Felbamate with product code 72578-057 is active and included in the NDC Directory. The product was first marketed by Viona Pharmaceuticals Inc on March 03, 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 NDC billing unit for package 72578-057-16?

    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 90.

    What is the 11-digit format for NDC 72578-057-16?

    The 11-digit format is 72578005716. 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 5-3-2 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
    5-3-272578-057-165-4-272578-0057-16