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  5. NDC Package Code: 53451-0103-1 Horizant

NDC Package 53451-0103-1 Horizant

Gabapentin Enacarbil Tablet, Extended Release 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:
53451-0103-1
Package Description:
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
53451-0103
Proprietary Name:
Horizant
Non-Proprietary Name:
Gabapentin Enacarbil
Substance Name:
Gabapentin Enacarbil
Usage Information:
This medication is used to treat moderate to severe restless legs syndrome. It is also used to relieve nerve pain following shingles (a painful rash due to herpes zoster infection). This condition is called postherpetic neuralgia. Gabapentin enacarbil is changed by your body to gabapentin. Gabapentin belongs to a class of drugs known as anti-seizure or anticonvulsant drugs.
11-Digit NDC Billing Format:
53451010301
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1101338 - gabapentin enacarbil 600 MG Extended Release Oral Tablet
  • RxCUI: 1101339 - Horizant 600 MG Extended Release Oral Tablet
  • RxCUI: 1101339 - gabapentin enacarbil 600 MG Extended Release Oral Tablet [Horizant]
  • RxCUI: 1482820 - gabapentin enacarbil 300 MG Extended Release Oral Tablet
  • RxCUI: 1482821 - Horizant 300 MG Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GABAPENTIN ENACARBIL 300 mg/1
    • Pharmacologic Class(es):
  • Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    NDA022399
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-01-2013
    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
    53451-0103-95 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53451-0103-1?

    The NDC Packaged Code 53451-0103-1 is assigned to a package of 30 tablet, extended release in 1 bottle, plastic of Horizant, a human prescription drug labeled by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals). The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 53451-0103 included in the NDC Directory?

    Yes, Horizant with product code 53451-0103 is active and included in the NDC Directory. The product was first marketed by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) on May 01, 2013 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 53451-0103-1?

    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 30.

    What is the 11-digit format for NDC 53451-0103-1?

    The 11-digit format is 53451010301. 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 5-4-1 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
    5-4-153451-0103-15-4-253451-0103-01