Oxybutynin Chloride
NDC Package 0615-7521-39

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 Ncs Healthcare Of Ky, Llc Dba Vangard Labs, this product is identified by NDC 0615-7521 and is authorized under FDA application NDA020897.

Identification & Billing

NDC Package Code
0615-7521-39
Package Description
30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
0615-7521
11-Digit Billing Format
00615752139

Clinical Specifications

Proprietary Name
Oxybutynin Chloride
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
Ncs Healthcare Of Ky, Llc Dba Vangard Labs
FDA Application #
NDA020897
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-10-2007
End Marketing Date
06-30-2011
Listing Expiration
06-30-2011
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 0615-7521-39 identifies a specific commercial package of 30 tablet, extended release in 1 blister pack of Oxybutynin Chloride, labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. 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 Ncs Healthcare Of Ky, Llc Dba Vangard Labs on May 10, 2007. The current certification is valid through June 30, 2011.

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 Ncs Healthcare Of Ky, Llc Dba Vangard Labs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00615752139. 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)
0615-7521-39
11-Digit CMS (5-4-2)
00615-7521-39

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