Safinamide Mesylate Powder
NDC Package 59285-031-01

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.

Safinamide Mesylate powders is safinamide is used with another medication (levodopa/carbidopa) to treat symptoms of Parkinson's disease. This formulation utilizes a powder delivery system. Marketed by Optimus Drugs Private Limited, this product is identified by NDC 59285-031.

Identification & Billing

NDC Package Code
59285-031-01
Package Description
50 kg in 1 DRUM
Product Code
59285-031
11-Digit Billing Format
59285003101

Clinical Specifications

Proprietary Name
Safinamide Mesylate
Non-Proprietary Name
Safinamide Mesylate
Substance Name
Safinamide Mesylate
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)
SAFINAMIDE MESYLATE 1 kg/kg
Usage Information
Safinamide is used with another medication (levodopa/carbidopa) to treat symptoms of Parkinson's disease. It can help improve symptoms such as shakiness, stiffness, and difficulty moving. It can also help reduce the amount of "off" time (periods of slow movement or stiffness). Safinamide belongs to a class of drugs known as MAO inhibitors. It works by increasing the levels of certain natural substances in the brain (such as dopamine). Parkinson's disease is thought to be caused by too little dopamine in the brain.

Regulatory & Marketing

Labeler Name
Optimus Drugs 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
07-20-2020
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 59285-031-01 identifies a specific commercial package of 50 kg in 1 drum of Safinamide Mesylate (UNFINISHED drug), a bulk ingredient labeled by Optimus Drugs Private Limited. This powder is formulated for use and contains safinamide mesylate 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 Optimus Drugs Private Limited on July 20, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Safinamide is used with another medication (levodopa/carbidopa) to treat symptoms of Parkinson's disease. It can help improve symptoms such as shakiness, stiffness, and difficulty moving. It can also help reduce the amount of "off" time (periods of slow movement or stiffness). Safinamide belongs to a class of drugs known as MAO inhibitors. It works by increasing the levels of certain natural substances in the brain (such as dopamine). Parkinson's disease is thought to be caused by too little dopamine in the brain.

How is this Optimus Drugs Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59285003101. 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)
59285-031-01
11-Digit CMS (5-4-2)
59285-0031-01

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