Oxytrol For Women Patch
NDC Package 0023-9637-08

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

Package Information

Oxytrol For Women (oxybutynin) patches is oxybutynin is used to treat an overactive bladder. This formulation utilizes a patch delivery system. Marketed by Allergan, Inc., this product is identified by NDC 0023-9637 and is authorized under FDA application NDA202211.

Identification & Billing

NDC Package Code
0023-9637-08
Package Description
32 PATCH in 1 CARTON / 4 d in 1 PATCH
Product Code
0023-9637
11-Digit Billing Format
00023963708
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Oxytrol For Women
Non-Proprietary Name
Oxybutynin
Substance Name
Oxybutynin
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
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
OXYBUTYNIN 3.9 mg/d
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Allergan, Inc.
Product Type
Human Otc Drug
FDA Application #
NDA202211
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2016
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 (0023-9637). Click a package code to view its specific billing and regulatory data.

0023-9637-04
16 PATCH in 1 CARTON / 4 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 0023-9637-08 identifies a specific commercial package of 32 patch in 1 carton / 4 d in 1 patch of Oxytrol For Women, a human over the counter drug labeled by Allergan, Inc.. This patch is formulated for transdermal use and contains oxybutynin 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 Allergan, Inc. on January 01, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Allergan, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00023963708. 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 (4-4-2)
0023-9637-08
11-Digit CMS (5-4-2)
00023-9637-08

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