Xadago Tablet, Film Coated
NDC Package 27505-110-30

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

Xadago (safinamide mesylate) tablets is safinamide is used with another medication (levodopa/carbidopa) to treat symptoms of Parkinson's disease. This formulation utilizes a tablet, film coated delivery system. Marketed by Mdd Us Operations Llc, A Subsidiary Of Supernus Pharmaceuticals, Inc., this product is identified by NDC 27505-110 and is authorized under FDA application NDA207145.

Identification & Billing

NDC Package Code
27505-110-30
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code
27505-110
11-Digit Billing Format
27505011030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xadago
Non-Proprietary Name
Safinamide Mesylate
Substance Name
Safinamide Mesylate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SAFINAMIDE MESYLATE 50 mg/1
Pharmacologic Class
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
Mdd Us Operations Llc, A Subsidiary Of Supernus Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA207145
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-08-2017
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 (27505-110). Click a package code to view its specific billing and regulatory data.

27505-110-14
1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK
27505-110-90
1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE

* 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 27505-110-30 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Xadago, a human prescription drug labeled by Mdd Us Operations Llc, A Subsidiary Of Supernus Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral 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 Mdd Us Operations Llc, A Subsidiary Of Supernus Pharmaceuticals, Inc. on May 08, 2017. 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 Mdd Us Operations Llc, A Subsidiary Of Supernus Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 27505011030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
27505-110-30
11-Digit CMS (5-4-2)
27505-0110-30

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