Oxybutynin Chloride
NDC Package 51079-628-19

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

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 Mylan Institutional Inc., this product is identified by NDC 51079-628 and is authorized under FDA application ANDA074625.

Identification & Billing

NDC Package Code
51079-628-19
Package Description
25 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET in 1 BLISTER PACK (51079-628-17)
Product Code
51079-628
11-Digit Billing Format
51079062819
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
25 EA

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
Mylan Institutional Inc.
FDA Application #
ANDA074625
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-1996
End Marketing Date
02-28-2014
Listing Expiration
02-28-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (51079-628). Click a package code to view its specific billing and regulatory data.

51079-628-20
100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET in 1 BLISTER PACK (51079-628-01)

* 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 51079-628-19 identifies a specific commercial package of 25 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack (51079-628-17) of Oxybutynin Chloride, labeled by Mylan Institutional 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 Mylan Institutional Inc. on February 01, 1996. The current certification is valid through February 28, 2014.

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 Mylan Institutional Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51079062819. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 25 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)
51079-628-19
11-Digit CMS (5-4-2)
51079-0628-19

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