NDC Package 50458-810-01 Ditropan XL

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:

50458-810-01

Package Description:

100 TABLET, EXTENDED RELEASE in 1 BOTTLE

Product Code:

50458-810

Proprietary Name:

Ditropan XL

Usage Information:

This is a long-acting form of oxybutynin that is used to treat overactive bladder and urinary conditions. 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. This medication is also used to treat children 6 years of age and older who have an overactive bladder due to certain nerve disorders (e.g., spina bifida).

11-Digit NDC Billing Format:

50458081001

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

100 EA

Labeler Name:

Janssen Pharmaceuticals, Inc.

Sample Package:

FDA Application Number:

NDA020897

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

06-26-1999

End Marketing Date:

09-30-2023

Listing Expiration Date:

09-30-2023

Exclude Flag:

Code Structure:

50458 - Janssen Pharmaceuticals, Inc.
- 50458-810 - Ditropan
  - 50458-810-01 - 100 TABLET, EXTENDED RELEASE 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.

Frequently Asked Questions

What is NDC 50458-810-01?

The NDC Packaged Code 50458-810-01 is assigned to a package of 100 tablet, extended release in 1 bottle of Ditropan XL, labeled by Janssen Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

Is NDC 50458-810 included in the NDC Directory?

No, Ditropan XL with product code 50458-810 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Janssen Pharmaceuticals, Inc. on June 26, 1999 and its listing in the NDC Directory is set to expire on September 30, 2023 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 50458-810-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

What is the 11-digit format for NDC 50458-810-01?

The 11-digit format is 50458081001. 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 5-3-2 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
5-3-2	50458-810-01	5-4-2	50458-0810-01

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