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  5. NDC Package Code: 45802-580-01 Scopolamine Transdermal System

NDC Package 45802-580-01 Scopolamine Transdermal System

Scolopamine Transdermal System Patch, Extended Release Transdermal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
45802-580-01
Package Description:
1 PATCH, EXTENDED RELEASE in 1 POUCH
Product Code:
45802-580
Proprietary Name:
Scopolamine Transdermal System
Non-Proprietary Name:
Scolopamine Transdermal System
Substance Name:
Scopolamine
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.
11-Digit NDC Billing Format:
45802058001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Padagis Israel Pharmaceuticals Ltd
    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(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Active Ingredient(s):
  • SCOPOLAMINE 1 mg/1
    • Pharmacologic Class(es):
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078830
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-13-2017
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    45802-580-4610 POUCH in 1 CARTON / 1 PATCH, EXTENDED RELEASE in 1 POUCH
    45802-580-6224 POUCH in 1 CARTON / 1 PATCH, EXTENDED RELEASE in 1 POUCH
    45802-580-844 POUCH in 1 CARTON / 1 PATCH, EXTENDED RELEASE in 1 POUCH

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 45802-580-01?

    The NDC Packaged Code 45802-580-01 is assigned to a package of 1 patch, extended release in 1 pouch of Scopolamine Transdermal System, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is patch, extended release and is administered via transdermal form.

    Is NDC 45802-580 included in the NDC Directory?

    Yes, Scopolamine Transdermal System with product code 45802-580 is active and included in the NDC Directory. The product was first marketed by Padagis Israel Pharmaceuticals Ltd on June 13, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 45802-580-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 45802-580-01?

    The 11-digit format is 45802058001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-245802-580-015-4-245802-0580-01