Oxytrol
NDC Package 52544-920-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Oxytrol is oxybutynin is used to treat an overactive bladder. Marketed by Actavis Pharma, Inc., this product is identified by NDC 52544-920 and is authorized under FDA application NDA021351.

Identification & Billing

NDC Package Code
52544-920-08
Package Description
8 POUCH in 1 BOX / 1 PATCH in 1 POUCH (52544-920-54) / 4 d in 1 PATCH
Product Code
11-Digit Billing Format
52544092008
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Oxytrol
Dosage Form
-
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
Actavis Pharma, Inc.
FDA Application #
NDA021351
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-26-2003
End Marketing Date
01-31-2020
Listing Expiration
01-31-2020
Exclude Flag
D
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 52544-920-08 identifies a specific commercial package of 8 pouch in 1 box / 1 patch in 1 pouch (52544-920-54) / 4 d in 1 patch of Oxytrol, labeled by Actavis Pharma, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Actavis Pharma, Inc. on February 26, 2003. The current certification is valid through January 31, 2020.

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 Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52544092008. 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 (5-3-2)
52544-920-08
11-Digit CMS (5-4-2)
52544-0920-08

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