Oxybutynin Chloride Tablet
NDC Package 43353-978-92

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-978 and is authorized under FDA application ANDA074625.

Identification & Billing

NDC Package Code
43353-978-92
Package Description
270 TABLET in 1 BOTTLE
Product Code
43353-978
11-Digit Billing Format
43353097892
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
270 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxybutynin Chloride
Non-Proprietary Name
Oxybutynin Chloride
Substance Name
Oxybutynin Chloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
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
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA074625
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-07-2011
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43353-978-92 identifies a specific commercial package of 270 tablet in 1 bottle of Oxybutynin Chloride, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 270 billable units per package. This tablet 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 Aphena Pharma Solutions - Tennessee, Llc on November 07, 2011. 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 Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353097892. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 270 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 (5-3-2)
43353-978-92
11-Digit CMS (5-4-2)
43353-0978-92

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