Miglustat Powder
NDC Package 42973-166-00

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Miglustat powders is miglustat is used for the long-term treatment of a certain rare genetic problem (Gaucher's disease). This formulation utilizes a powder delivery system. Marketed by Apicore Pharmaceuticals Private Limited, this product is identified by NDC 42973-166.

Identification & Billing

NDC Package Code
42973-166-00
Package Description
50 kg in 1 DRUM
Product Code
42973-166
11-Digit Billing Format
42973016600

Clinical Specifications

Proprietary Name
Miglustat
Non-Proprietary Name
Miglustat
Substance Name
Miglustat
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
MIGLUSTAT 1 kg/kg
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
Apicore Pharmaceuticals Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-01-2011
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 42973-166-00 identifies a specific commercial package of 50 kg in 1 drum of Miglustat (UNFINISHED drug), a bulk ingredient labeled by Apicore Pharmaceuticals Private Limited. This powder is formulated for 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 Apicore Pharmaceuticals Private Limited on December 01, 2011. 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 Apicore Pharmaceuticals Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42973016600. 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)
42973-166-00
11-Digit CMS (5-4-2)
42973-0166-00

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