Oxybutynin Chloride
NDC Package 70985-021-01

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 Drug Ocean Llc, this product is identified by NDC 70985-021 and is authorized under FDA application ANDA206121.

Identification & Billing

NDC Package Code
70985-021-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
70985-021
11-Digit Billing Format
70985002101

Clinical Specifications

Proprietary Name
Oxybutynin Chloride Extended Release
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
Drug Ocean Llc
FDA Application #
ANDA206121
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-05-2023
End Marketing Date
11-01-2025
Listing Expiration
11-01-2025
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 (70985-021). Click a package code to view its specific billing and regulatory data.

70985-021-02
500 TABLET, EXTENDED RELEASE in 1 BOTTLE

* 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 70985-021-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Oxybutynin Chloride Extended Release, labeled by Drug Ocean Llc. 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 Drug Ocean Llc on October 05, 2023. The current certification is valid through November 01, 2025.

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 Drug Ocean Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70985002101. 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)
70985-021-01
11-Digit CMS (5-4-2)
70985-0021-01

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