Oxybutynin Chloride Syrup
NDC Package 17856-0149-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Oxybutynin Chloride syrups is oxybutynin is used to treat certain bladder and urinary conditions (e.g., overactive bladder). This formulation utilizes a syrup delivery system. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-0149 and is authorized under FDA application ANDA074520.

Identification & Billing

NDC Package Code
17856-0149-1
Package Description
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 5 mL in 1 CUP, UNIT-DOSE
Product Code
17856-0149
11-Digit Billing Format
17856014901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxybutynin Chloride
Non-Proprietary Name
Oxybutynin Chloride
Substance Name
Oxybutynin Chloride
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OXYBUTYNIN CHLORIDE 5 mg/5mL
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
Atlantic Biologicals Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA074520
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-29-1996
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 17856-0149-1 identifies a specific commercial package of 72 cup, unit-dose in 1 box, unit-dose / 5 ml in 1 cup, unit-dose of Oxybutynin Chloride, a human prescription drug labeled by Atlantic Biologicals Corp.. This syrup 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 Atlantic Biologicals Corp. on March 29, 1996. 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 Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856014901. 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 (5-4-1)
17856-0149-1
11-Digit CMS (5-4-2)
17856-0149-01

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