Xadago Tablet, Film Coated
NDC Package 27505-110-90
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
- RxCUI: 1922466 - safinamide 50 MG Oral Tablet
- RxCUI: 1922466 - safinamide 50 MG (as safinamide mesylate 65.88 MG) Oral Tablet
- RxCUI: 1922472 - Xadago 50 MG Oral Tablet
- RxCUI: 1922472 - safinamide 50 MG Oral Tablet [Xadago]
- RxCUI: 1922472 - Xadago 50 MG (as safinamide mesylate 65.88 MG) Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 27505 - Mdd Us Operations Llc, A Subsidiary Of Supernus Pharmaceuticals, Inc.
- 27505-110 - Xadago
- 27505-110-90 - 1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE
- 27505-110 - Xadago
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.
* 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 27505-110-90 identifies a specific commercial package of 1 bottle in 1 carton / 90 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: 27505011090. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
