Oxybutynin Base Powder
NDC Package 49169-1013-0

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Oxybutynin Base powders is oxybutynin is used to treat an overactive bladder. This formulation utilizes a powder delivery system. Marketed by Pcas France, this product is identified by NDC 49169-1013.

Identification & Billing

NDC Package Code
49169-1013-0
Package Description
25 kg in 1 DRUM
Product Code
49169-1013
11-Digit Billing Format
49169101300

Clinical Specifications

Proprietary Name
Oxybutynin Base
Non-Proprietary Name
Oxybutynin Base
Substance Name
Oxybutynin
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
OXYBUTYNIN 1 kg/kg
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
Pcas France
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
08-14-2009
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 49169-1013-0 identifies a specific commercial package of 25 kg in 1 drum of Oxybutynin Base (UNFINISHED drug), a bulk ingredient labeled by Pcas France. This powder is formulated for use and contains oxybutynin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Pcas France on August 14, 2009. The current certification is valid through December 31, 2026.

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 Pcas France product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49169101300. 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)
49169-1013-0
11-Digit CMS (5-4-2)
49169-1013-00

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