Opfolda Capsule
NDC Package 71904-300-01

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

Package Information

Opfolda (miglustat) capsules is miglustat is used for the long-term treatment of a certain rare genetic problem (Gaucher's disease). This formulation utilizes a capsule delivery system. Marketed by Amicus Therapeutics Us, Llc, this product is identified by NDC 71904-300 and is authorized under FDA application NDA215211.

Identification & Billing

NDC Package Code
71904-300-01
Package Description
4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC / 1 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
71904-300
11-Digit Billing Format
71904030001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Opfolda
Non-Proprietary Name
Miglustat
Substance Name
Miglustat
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)
MIGLUSTAT 65 mg/1
Pharmacologic Class
Usage Information
Miglustat is used for the long-term treatment of a certain rare genetic problem (Gaucher's disease). It works by decreasing the amount of a certain natural fatty substance (glucosylceramide) that builds up due to this condition. This can help improve symptoms of Gaucher's disease, such as tiredness, pain in the joints/bones, and a swollen liver or spleen.

Regulatory & Marketing

Labeler Name
Amicus Therapeutics Us, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA215211
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-11-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71904-300). Click a package code to view its specific billing and regulatory data.

71904-300-02
24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC / 1 CAPSULE in 1 BOTTLE, PLASTIC
71904-300-03
100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC / 1 CAPSULE in 1 BOTTLE, PLASTIC

* 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 71904-300-01 identifies a specific commercial package of 4 bottle, plastic in 1 bottle, plastic / 1 capsule in 1 bottle, plastic of Opfolda, a human prescription drug labeled by Amicus Therapeutics Us, Llc. This capsule is formulated for oral use and contains miglustat 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 October 11, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Miglustat is used for the long-term treatment of a certain rare genetic problem (Gaucher's disease). It works by decreasing the amount of a certain natural fatty substance (glucosylceramide) that builds up due to this condition. This can help improve symptoms of Gaucher's disease, such as tiredness, pain in the joints/bones, and a swollen liver or spleen.

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: 71904030001. 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)
71904-300-01
11-Digit CMS (5-4-2)
71904-0300-01

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