Oxybutynin Chloride Powder
NDC Package 65085-0013-2

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 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 Chloride powders is this is a long-acting form of oxybutynin that is used to treat overactive bladder and urinary conditions. This formulation utilizes a powder delivery system. Marketed by Piramal Pharma Limited, this product is identified by NDC 65085-0013.

Identification & Billing

NDC Package Code
65085-0013-2
Package Description
10 kg in 1 DRUM
Product Code
65085-0013
11-Digit Billing Format
65085001302

Clinical Specifications

Proprietary Name
Oxybutynin Chloride
Non-Proprietary Name
Oxybutynin Chloride
Substance Name
Oxybutynin Chloride
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 CHLORIDE 25 kg/25kg
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
Piramal Pharma Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-27-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65085-0013). Click a package code to view its specific billing and regulatory data.

65085-0013-1
5 kg in 1 DRUM
65085-0013-3
15 kg in 1 DRUM
65085-0013-4
20 kg in 1 DRUM
65085-0013-5
25 kg in 1 DRUM
65085-0013-6
5 kg in 1 DRUM
65085-0013-7
10 kg in 1 DRUM
65085-0013-8
10 kg in 1 DRUM
65085-0013-9
15 kg in 1 DRUM

* 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 65085-0013-2 identifies a specific commercial package of 10 kg in 1 drum of Oxybutynin Chloride (UNFINISHED drug), a bulk ingredient labeled by Piramal Pharma Limited. This powder is formulated for use and contains oxybutynin chloride 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 Piramal Pharma Limited on December 27, 2018. The current certification is valid through December 31, 2026.

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 Piramal Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65085001302. 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)
65085-0013-2
11-Digit CMS (5-4-2)
65085-0013-02

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