Oxybutynin Chloride
NDC Package 68071-2013-6

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

Package Information

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

Oxybutynin Chloride is oxybutynin is used to treat certain bladder and urinary conditions (e.g., overactive bladder). Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-2013 and is authorized under FDA application ANDA078503.

Identification & Billing

NDC Package Code
68071-2013-6
Package Description
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
68071-2013
11-Digit Billing Format
68071201306

Clinical Specifications

Proprietary Name
Oxybutynin Chloride Extended Release
Dosage Form
-
Usage Information
Oxybutynin is used to treat certain bladder and urinary conditions (e.g., overactive bladder). It relaxes the muscles in the bladder to help decrease problems of urgency and frequent urination. Oxybutynin belongs to a class of drugs known as antispasmodics. The manufacturer does not recommend using this medication in children younger than 5 years of age.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals, Inc.
FDA Application #
ANDA078503
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2009
End Marketing Date
12-31-2018
Listing Expiration
12-31-2018
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 68071-2013-6 identifies a specific commercial package of 60 tablet, extended release in 1 bottle of Oxybutynin Chloride Extended Release, labeled by Nucare Pharmaceuticals, 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 Nucare Pharmaceuticals, Inc. on March 01, 2009. The current certification is valid through December 31, 2018.

What are the primary indications for this medication?

Oxybutynin is used to treat certain bladder and urinary conditions (e.g., overactive bladder). It relaxes the muscles in the bladder to help decrease problems of urgency and frequent urination. Oxybutynin belongs to a class of drugs known as antispasmodics. The manufacturer does not recommend using this medication in children younger than 5 years of age.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071201306. 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 (5-4-1)
68071-2013-6
11-Digit CMS (5-4-2)
68071-2013-06

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