NDC Package 0603-1491-58 Oxybutynin Chloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory .

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0603-1491-58

Package Description:

473 mL in 1 BOTTLE

Product Code:

0603-1491

Proprietary Name:

Oxybutynin Chloride

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.

11-Digit NDC Billing Format:

00603149158

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

473 ML

Labeler Name:

Qualitest Pharmaceuticals

Sample Package:

FDA Application Number:

ANDA076682

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

12-28-2004

End Marketing Date:

01-31-2018

Listing Expiration Date:

01-31-2018

Exclude Flag:

Code Structure:

0603 - Qualitest Pharmaceuticals
- 0603-1491 - Oxybutynin Chloride
  - 0603-1491-58 - 473 mL in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
0603-1491-54	118 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0603-1491-58?

The NDC Packaged Code 0603-1491-58 is assigned to a package of 473 ml in 1 bottle of Oxybutynin Chloride, labeled by Qualitest Pharmaceuticals. The product's dosage form is and is administered via form.

Is NDC 0603-1491 included in the NDC Directory?

The product was first marketed by Qualitest Pharmaceuticals on December 28, 2004 and its listing in the NDC Directory is set to expire on January 31, 2018 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0603-1491-58?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

What is the 11-digit format for NDC 0603-1491-58?

The 11-digit format is 00603149158. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0603-1491-58	5-4-2	00603-1491-58

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