Oxybutynin Chloride Tablet, Extended Release
NDC Package 0904-6570-04

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 Chloride tablets is oxybutynin is used to treat certain bladder and urinary conditions (e.g., overactive bladder). This formulation utilizes a tablet, extended release delivery system. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-6570 and is authorized under FDA application ANDA204010.

Identification & Billing

NDC Package Code
0904-6570-04
Package Description
30 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
0904-6570
11-Digit Billing Format
00904657004
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 863636 - oxyBUTYnin chloride 5 MG 24HR Extended Release Oral Tablet
  • RxCUI: 863636 - 24 HR oxybutynin chloride 5 MG Extended Release Oral Tablet
  • RxCUI: 863636 - oxybutynin chloride 5 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Oxybutynin Chloride
Non-Proprietary Name
Oxybutynin Chloride
Substance Name
Oxybutynin Chloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OXYBUTYNIN CHLORIDE 5 mg/1
Pharmacologic Class
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
Major Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA204010
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-02-2015
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 (0904-6570). Click a package code to view its specific billing and regulatory data.

0904-6570-06
50 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
0904-6570-61
100 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

* 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 0904-6570-04 identifies a specific commercial package of 30 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack of Oxybutynin Chloride, a human prescription drug labeled by Major Pharmaceuticals. This tablet, 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 Major Pharmaceuticals on November 02, 2015. The current certification is valid through December 31, 2026.

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 Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904657004. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (4-4-2)
0904-6570-04
11-Digit CMS (5-4-2)
00904-6570-04

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