Selegiline Hcl Powder
NDC Package 46438-0062-1

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.

Selegiline Hcl powders is a medication used to treat movement disorders caused by Parkinson's disease. This formulation utilizes a powder delivery system. Marketed by Dipharma Francis Srl, this product is identified by NDC 46438-0062.

Identification & Billing

NDC Package Code
46438-0062-1
Package Description
25 kg in 1 DRUM
Product Code
46438-0062
11-Digit Billing Format
46438006201

Clinical Specifications

Proprietary Name
Selegiline Hcl
Non-Proprietary Name
Selegiline Hcl
Substance Name
Selegiline Hydrochloride
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)
SELEGILINE HYDROCHLORIDE 1 kg/kg
Usage Information
This medication is used to treat movement disorders caused by Parkinson's disease. It does not cure Parkinson's disease, but it may improve shakiness (tremor), muscle stiffness, loss of normal movement as your dose of other Parkinson's medication wears off (end-of-dose failure), and sudden switching between normal movement and stiffness ("on-off" problems). It may improve your range of motion and ability to walk, dress, and exercise. Selegiline is usually used in combination with other medicines (e.g., levodopa, carbidopa). Selegiline is an enzyme blocker (MAO inhibitor) that works by slowing the breakdown of certain natural substances in the brain (neurotransmitters such as dopamine, norepinephrine, and serotonin).

Regulatory & Marketing

Labeler Name
Dipharma Francis Srl
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
03-01-2012
Listing Expiration
12-31-2027
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 46438-0062-1 identifies a specific commercial package of 25 kg in 1 drum of Selegiline Hcl (UNFINISHED drug), a bulk ingredient labeled by Dipharma Francis Srl. This powder is formulated for use and contains selegiline 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 Dipharma Francis Srl on March 01, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat movement disorders caused by Parkinson's disease. It does not cure Parkinson's disease, but it may improve shakiness (tremor), muscle stiffness, loss of normal movement as your dose of other Parkinson's medication wears off (end-of-dose failure), and sudden switching between normal movement and stiffness ("on-off" problems). It may improve your range of motion and ability to walk, dress, and exercise. Selegiline is usually used in combination with other medicines (e.g., levodopa, carbidopa). Selegiline is an enzyme blocker (MAO inhibitor) that works by slowing the breakdown of certain natural substances in the brain (neurotransmitters such as dopamine, norepinephrine, and serotonin).

How is this Dipharma Francis Srl product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46438006201. 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 (5-4-1)
46438-0062-1
11-Digit CMS (5-4-2)
46438-0062-01

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