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  5. NDC Package Code: 71904-100-01 Galafold

NDC Package 71904-100-01 Galafold

Migalastat Hydrochloride Capsule 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:
71904-100-01
Package Description:
14 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK
Product Code:
71904-100
Proprietary Name:
Galafold
Non-Proprietary Name:
Migalastat Hydrochloride
Substance Name:
Migalastat Hydrochloride
Usage Information:
This medication is used for long-term treatment in people with a certain inherited disease (Fabry disease). In Fabry disease, a certain enzyme in your body (alpha-galactosidase) does not work the way it should. This leads to a buildup of a certain fatty substance in your kidneys, heart, and other organs. Migalastat works by helping alpha-galactosidase work better so it can remove the fatty substance. Treatment can decrease some symptoms caused by Fabry disease, such as abdominal cramps, diarrhea, burning pain in the hands and feet, heat intolerance, skin rash, kidney/heart disease, or stroke.
11-Digit NDC Billing Format:
71904010001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
14 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2054257 - migALAstat 123 MG Oral Capsule
  • RxCUI: 2054257 - migalastat 123 MG Oral Capsule
  • RxCUI: 2054257 - migalastat 123 MG (as migalastat HCl 150 MG) Oral Capsule
  • RxCUI: 2054263 - Galafold 123 MG Oral Capsule
  • RxCUI: 2054263 - migalastat 123 MG Oral Capsule [Galafold]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amicus Therapeutics Us, Llc
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • MIGALASTAT HYDROCHLORIDE 123 mg/1
    • Sample Package:
    No
    FDA Application Number:
    NDA208623
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-10-2018
    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 71904-100-01?

    The NDC Packaged Code 71904-100-01 is assigned to a package of 14 blister pack in 1 carton / 1 capsule in 1 blister pack of Galafold, a human prescription drug labeled by Amicus Therapeutics Us, Llc. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 14 billable units per package.

    Is NDC 71904-100 included in the NDC Directory?

    Yes, Galafold with product code 71904-100 is active and included in the NDC Directory. The product was first marketed by Amicus Therapeutics Us, Llc on August 10, 2018 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 71904-100-01?

    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 14.

    What is the 11-digit format for NDC 71904-100-01?

    The 11-digit format is 71904010001. 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
    5-3-271904-100-015-4-271904-0100-01