Scopolamine Transdermal System Patch, Extended Release
NDC Package 45802-580-01
Package Information
Scopolamine Transdermal System patches is this skin patch is used to prevent nausea and vomiting caused by motion sickness or recovery from anesthesia and surgery. This formulation utilizes a patch, extended release delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-580 and is authorized under FDA application ANDA078830.
Identification & Billing
- RxCUI: 226552 - scopolamine 1 MG 3 Day Transdermal System
- RxCUI: 226552 - 72 HR scopolamine 0.0139 MG/HR Transdermal System
- RxCUI: 226552 - scopolamine 0.0139 MG/HR 72 HR Transdermal Patch
- RxCUI: 226552 - scopolamine 0.3336 MG/Day 72 HR Transdermal Patch
- RxCUI: 226552 - scopolamine 1.3 MG 3 Day Transdermal System
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 45802 - Padagis Israel Pharmaceuticals Ltd
- 45802-580 - Scopolamine Transdermal System
- 45802-580-01 - 1 PATCH, EXTENDED RELEASE in 1 POUCH
- 45802-580 - Scopolamine Transdermal System
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 (45802-580). 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 45802-580-01 identifies a specific commercial package of 1 patch, extended release in 1 pouch of Scopolamine Transdermal System, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This patch, extended release is formulated for transdermal use and contains scopolamine 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 Padagis Israel Pharmaceuticals Ltd on June 13, 2017.
What are the primary indications for this medication?
This skin patch is used to prevent nausea and vomiting caused by motion sickness or recovery from anesthesia and surgery. This medication works by correcting the imbalance of natural substances (acetylcholine and norepinephrine) that can occur in motion sickness. It also blocks certain signals to the brain that can cause nausea and vomiting. This medication is not recommended for use in children.
How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802058001. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
