Neupro Patch, Extended Release
NDC Package 50474-802-17

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

Neupro (rotigotine) patches is rotigotine is used alone or with other medications to treat Parkinson's disease. This formulation utilizes a patch, extended release delivery system. Marketed by Ucb, Inc., this product is identified by NDC 50474-802 and is authorized under FDA application NDA021829.

Identification & Billing

NDC Package Code
50474-802-17
Package Description
7 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 24 h in 1 PATCH
Product Code
50474-802
11-Digit Billing Format
50474080217
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Neupro
Non-Proprietary Name
Rotigotine
Substance Name
Rotigotine
Dosage Form
Patch, Extended Release - A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
ROTIGOTINE 2 mg/24h
Pharmacologic Class
Usage Information
Rotigotine is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. Rotigotine is also used to treat restless legs syndrome (RLS). Rotigotine is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

Regulatory & Marketing

Labeler Name
Ucb, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021829
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-02-2012
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 (50474-802). Click a package code to view its specific billing and regulatory data.

50474-802-03
30 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 24 h in 1 PATCH

* 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 50474-802-17 identifies a specific commercial package of 7 pouch in 1 carton / 1 patch in 1 pouch / 24 h in 1 patch of Neupro, a human prescription drug labeled by Ucb, Inc.. This patch, extended release is formulated for transdermal use and contains rotigotine 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 Ucb, Inc. on April 02, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Rotigotine is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. Rotigotine is also used to treat restless legs syndrome (RLS). Rotigotine is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.

How is this Ucb, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50474080217. 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)
50474-802-17
11-Digit CMS (5-4-2)
50474-0802-17

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