Galafold Capsule
NDC Package 71904-100-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Galafold (migalastat hydrochloride) capsules is a medication used for long-term treatment in people with a certain inherited disease (Fabry disease). This formulation utilizes a capsule delivery system. Marketed by Amicus Therapeutics Us, Llc, this product is identified by NDC 71904-100 and is authorized under FDA application NDA208623.

Identification & Billing

NDC Package Code
71904-100-01
Package Description
14 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK
Product Code
71904-100
11-Digit Billing Format
71904010001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
14 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Galafold
Non-Proprietary Name
Migalastat Hydrochloride
Substance Name
Migalastat Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MIGALASTAT HYDROCHLORIDE 123 mg/1
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.

Regulatory & Marketing

Labeler Name
Amicus Therapeutics Us, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA208623
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-10-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71904-100-01 identifies a specific commercial 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. This product is billed for "EA" each discreet unit and contains an estimated amount of 14 billable units per package. This capsule is formulated for oral use and contains migalastat hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amicus Therapeutics Us, Llc on August 10, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Amicus Therapeutics Us, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71904010001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 14 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
71904-100-01
11-Digit CMS (5-4-2)
71904-0100-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.