Ditropan
NDC Package 17314-8501-1

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.

Ditropan is this is a long-acting form of oxybutynin that is used to treat overactive bladder and urinary conditions. Marketed by Alza Corporation, this product is identified by NDC 17314-8501 and is authorized under FDA application NDA020897.

Identification & Billing

NDC Package Code
17314-8501-1
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
17314-8501
11-Digit Billing Format
17314850101

Clinical Specifications

Proprietary Name
Ditropan XL
Dosage Form
-
Usage Information
This is a long-acting form of oxybutynin that is used to treat overactive bladder and urinary conditions. 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. This medication is also used to treat children 6 years of age and older who have an overactive bladder due to certain nerve disorders (e.g., spina bifida).

Regulatory & Marketing

Labeler Name
Alza Corporation
FDA Application #
NDA020897
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-26-1999
End Marketing Date
01-31-2010
Listing Expiration
01-31-2010
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 17314-8501-1 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Ditropan XL, labeled by Alza Corporation. 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 Alza Corporation on June 26, 1999. The current certification is valid through January 31, 2010.

What are the primary indications for this medication?

This is a long-acting form of oxybutynin that is used to treat overactive bladder and urinary conditions. 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. This medication is also used to treat children 6 years of age and older who have an overactive bladder due to certain nerve disorders (e.g., spina bifida).

How is this Alza Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17314850101. 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)
17314-8501-1
11-Digit CMS (5-4-2)
17314-8501-01

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