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NDC 10019-008 Transderm Scop

Scopolamine Patch, Extended Release Transdermal - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 10019-008?
  4. Transderm Scop Uses
  5. Active Ingredients
  6. NDC to RxNorm Crosswalk
  7. Pharmacologic Classes

Product Information

Get all the details for National Drug Code (NDC) 10019-008 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
10019-008
Proprietary Name:
Transderm Scop
Non-Proprietary Name: [1]
Scopolamine
Substance Name: [2]
Scopolamine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Labeler Name: [5]
Baxter Healthcare Corporation
Labeler Code:
10019
Product Label ID:
b877a694-a1d0-4280-937a-a06820b12a88
FDA Application Number: [6]
NDA017874
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
12-01-2016
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
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Product Details

What is NDC 10019-008?

The NDC code 10019-008 is assigned by the FDA to the product Transderm Scop which is a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Transderm Scop is scopolamine. The product's dosage form is patch, extended release and is administered via transdermal form. The product is distributed in 3 packages with assigned NDC codes 10019-008-04 4 pouch in 1 box / 1 patch in 1 pouch / 3 d in 1 patch, 10019-008-10 10 pouch in 1 box / 1 patch in 1 pouch / 3 d in 1 patch, 10019-008-24 24 pouch in 1 box / 1 patch in 1 pouch / 3 d in 1 patch. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Transderm Scop?

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.

What are Transderm Scop Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • SCOPOLAMINE 1 mg/3d - An alkaloid from SOLANACEAE, especially DATURA and SCOPOLIA. Scopolamine and its quaternary derivatives act as antimuscarinics like ATROPINE, but may have more central nervous system effects. Its many uses include an anesthetic premedication, the treatment of URINARY INCONTINENCE and MOTION SICKNESS, an antispasmodic, and a mydriatic and cycloplegic.

What is the NDC to RxNorm Crosswalk for Transderm Scop?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes for Transderm Scop?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".