NDC 0023-6153 Oxytrol

Oxybutynin Patch Transdermal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0023-6153
Proprietary Name:
Oxytrol
Non-Proprietary Name: [1]
Oxybutynin
Substance Name: [2]
Oxybutynin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route(s): [4]
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
  • Labeler Name: [5]
    Allergan, Inc.
    Labeler Code:
    0023
    FDA Application Number: [6]
    NDA021351
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    02-26-2003
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Imprint(s):
    OXYTROL3;9MG;DAY

    Product Packages

    NDC Code 0023-6153-08

    Package Description: 8 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 4 d in 1 PATCH

    Price per Unit: $80.88175 per EA

    Product Details

    What is NDC 0023-6153?

    The NDC code 0023-6153 is assigned by the FDA to the product Oxytrol which is a human prescription drug product labeled by Allergan, Inc.. The generic name of Oxytrol is oxybutynin. The product's dosage form is patch and is administered via transdermal form. The product is distributed in a single package with assigned NDC code 0023-6153-08 8 pouch in 1 box / 1 patch in 1 pouch / 4 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 Oxytrol?

    Oxybutynin is used to treat an overactive bladder. By relaxing the muscles in the bladder, oxybutynin improves symptoms such as the inability to control urination (incontinence), feeling that one has to urinate (urgency), and having to go to the bathroom often (frequency). This medication belongs to the class of drugs known as antispasmodics. This medication is not recommended for use in children younger than 5 years of age. Consult your doctor for more information. Unless otherwise directed by your doctor, the over-the-counter product should only be used by adult women who have symptoms of overactive bladder for at least 2 months. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

    What are Oxytrol 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.

    Which are Oxytrol UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Oxytrol Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Oxytrol?

    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:
    • RxCUI: 403799 - oxyBUTYnin 3.9 MG/Day Twice Weekly Transdermal System
    • RxCUI: 403799 - 84 HR oxybutynin 0.162 MG/HR Transdermal System
    • RxCUI: 403799 - oxybutynin 0.162 MG/HR 84 HR Transdermal Patch
    • RxCUI: 403799 - oxybutynin 3.9 MG/Day Twice Weekly Transdermal Patch
    • RxCUI: 403799 - oxybutynin 3.9 MG/Day Twice Weekly Transdermal System

    Which are the Pharmacologic Classes for Oxytrol?

    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.

    Patient Education

    Oxybutynin Transdermal Patch


    Oxybutynin transdermal patches are used to treat an overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination). Oxybutynin is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles.
    [Learn More]


    * 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".