Oxybutynin Tablet, Film Coated, Extended Release
NDC Package 68382-256-06

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

Oxybutynin tablets is oxybutynin is used to treat an overactive bladder. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 68382-256 and is authorized under FDA application ANDA202332.

Identification & Billing

NDC Package Code
68382-256-06
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
68382-256
11-Digit Billing Format
68382025606
RxNorm Crosswalk
  • RxCUI: 863619 - oxyBUTYnin chloride 10 MG 24HR Extended Release Oral Tablet
  • RxCUI: 863619 - 24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet
  • RxCUI: 863619 - oxybutynin chloride 10 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 863628 - oxyBUTYnin chloride 15 MG 24HR Extended Release Oral Tablet
  • RxCUI: 863628 - 24 HR oxybutynin chloride 15 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Oxybutynin
Non-Proprietary Name
Oxybutynin
Substance Name
Oxybutynin Chloride
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OXYBUTYNIN CHLORIDE 10 mg/1
Pharmacologic Class
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
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202332
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-10-2017
Listing Expiration
12-31-2026
Exclude Flag
N
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 (68382-256). Click a package code to view its specific billing and regulatory data.

68382-256-01
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
68382-256-05
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
68382-256-14
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
68382-256-16
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
68382-256-77
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-256-30)

* 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 68382-256-06 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Oxybutynin, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. This tablet, film coated, extended release is formulated for oral 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 Zydus Pharmaceuticals Usa Inc. on August 10, 2017. 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 Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382025606. 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)
68382-256-06
11-Digit CMS (5-4-2)
68382-0256-06

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