NDC Package 54868-4855-0 Colazal

View Billable Units, 11-Digit Format, RxNorm

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:
54868-4855-0
Package Description:
280 CAPSULE in 1 BOTTLE
Product Code:
Proprietary Name:
Colazal
Usage Information:
Balsalazide is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Balsalazide belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon.
11-Digit NDC Billing Format:
54868485500
Labeler Name:
Physicians Total Care, Inc.
Sample Package:
No
FDA Application Number:
NDA020610
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
06-09-2005
End Marketing Date:
06-30-2011
Listing Expiration Date:
06-30-2011
Exclude Flag:
D
Code Structure:

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.

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Frequently Asked Questions

What is NDC 54868-4855-0?

The NDC Packaged Code 54868-4855-0 is assigned to a package of 280 capsule in 1 bottle of Colazal, labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form.

Is NDC 54868-4855 included in the NDC Directory?

No, Colazal with product code 54868-4855 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Physicians Total Care, Inc. on June 09, 2005 and its listing in the NDC Directory is set to expire on June 30, 2011 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 54868-4855-0?

The 11-digit format is 54868485500. 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 5-4-1 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-154868-4855-05-4-254868-4855-00