Oxybutynin Chloride
NDC Package 0904-2821-61

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 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 Major Pharmaceuticals, this product is identified by NDC 0904-2821 and is authorized under FDA application ANDA071655.

Identification & Billing

NDC Package Code
0904-2821-61
Package Description
100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
Product Code
0904-2821
11-Digit Billing Format
00904282161
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Oxybutynin Chloride
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
Major Pharmaceuticals
FDA Application #
ANDA071655
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-03-2004
End Marketing Date
09-30-2023
Listing Expiration
09-30-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0904-2821-61 identifies a specific commercial package of 100 blister pack in 1 carton / 1 tablet in 1 blister pack of Oxybutynin Chloride, labeled by Major Pharmaceuticals. 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 Major Pharmaceuticals on February 03, 2004. The current certification is valid through September 30, 2023.

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: 00904282161. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
0904-2821-61
11-Digit CMS (5-4-2)
00904-2821-61

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