Miglustat
NDC Package 42799-708-01

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Miglustat is used for the long-term treatment of a certain rare genetic problem (Gaucher's disease). Marketed by Edenbridge Pharmaceuticals Llc., this product is identified by NDC 42799-708 and is authorized under FDA application ANDA209821.

Identification & Billing

NDC Package Code
42799-708-01
Package Description
6 BLISTER PACK in 1 CARTON / 15 CAPSULE in 1 BLISTER PACK
Product Code
42799-708
11-Digit Billing Format
42799070801

Clinical Specifications

Proprietary Name
Miglustat
Dosage Form
-
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
Edenbridge Pharmaceuticals Llc.
FDA Application #
ANDA209821
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-06-2020
End Marketing Date
10-31-2023
Listing Expiration
10-31-2023
Exclude Flag
D
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 (42799-708). Click a package code to view its specific billing and regulatory data.

42799-708-15
1 BLISTER PACK in 1 CARTON / 15 CAPSULE in 1 BLISTER PACK

* 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 42799-708-01 identifies a specific commercial package of 6 blister pack in 1 carton / 15 capsule in 1 blister pack of Miglustat, labeled by Edenbridge Pharmaceuticals Llc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Edenbridge Pharmaceuticals Llc. on August 06, 2020. The current certification is valid through October 31, 2023.

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 Edenbridge Pharmaceuticals Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42799070801. 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)
42799-708-01
11-Digit CMS (5-4-2)
42799-0708-01

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