Transderm Scop Patch, Extended Release
NDC Package 10019-008-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Transderm Scop (scopolamine) 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 Baxter Healthcare Corporation, this product is identified by NDC 10019-008 and is authorized under FDA application NDA017874.

Identification & Billing

NDC Package Code
10019-008-01
Package Description
1 PATCH in 1 POUCH / 3 d in 1 PATCH
Product Code
11-Digit Billing Format
10019000801
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
Transderm Scop
Non-Proprietary Name
Scopolamine
Substance Name
Scopolamine
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)
Usage Information
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.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA017874
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-01-2016
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 (10019-008). Click a package code to view its specific billing and regulatory data.

4 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
10 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 3 d in 1 PATCH
24 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 3 d 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 10019-008-01 identifies a specific commercial package of 1 patch in 1 pouch / 3 d in 1 patch of Transderm Scop, a human prescription drug labeled by Baxter Healthcare Corporation. 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 Baxter Healthcare Corporation on December 01, 2016. The current certification is valid through December 31, 2026.

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 Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10019000801. 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)
10019-008-01
11-Digit CMS (5-4-2)
10019-0008-01

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