Scopolamine Patch, Extended Release
NDC Package 68071-3994-4

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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 Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-3994 and is authorized under FDA application ANDA212342.

Identification & Billing

NDC Package Code
68071-3994-4
Package Description
4 POUCH in 1 CARTON / 1 PATCH, EXTENDED RELEASE in 1 POUCH
Product Code
68071-3994
11-Digit Billing Format
68071399404
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Scopolamine
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)
SCOPOLAMINE 1.5 mg/1
Pharmacologic Class
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
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212342
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-24-2020
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68071-3994-4 identifies a specific commercial package of 4 pouch in 1 carton / 1 patch, extended release in 1 pouch of Scopolamine, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. 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 Nucare Pharmaceuticals, Inc. on November 24, 2020. The current certification is valid through December 31, 2027.

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 Nucare Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071399404. 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 (5-4-1)
68071-3994-4
11-Digit CMS (5-4-2)
68071-3994-04

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