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  5. NDC Package Code: 63552-043-03 Mesalamine

NDC Package 63552-043-03 Mesalamine

Capsule - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
63552-043-03
Package Description:
12 BOTTLE, PLASTIC in 1 CASE / 120 CAPSULE in 1 BOTTLE, PLASTIC
Product Code:
63552-043
Non-Proprietary Name:
Mesalamine
Substance Name:
Mesalamine
Usage Information:
This medication 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. Mesalamine belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon.
11-Digit NDC Billing Format:
63552004303
Product Type:
Drug For Further Processing
Labeler Name:
Patheon Manufacturing Services Llc
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s):
MESALAMINE 500 mg/1
Sample Package:
N/A
Marketing Category:
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date:
07-08-2004
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Unfinished Product:
Yes
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.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
63552-043-0260 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACK (63552-043-01)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 63552-043-03?

The NDC Packaged Code 63552-043-03 is assigned to an UNFINISHED drug package of 12 bottle, plastic in 1 case / 120 capsule in 1 bottle, plastic of Mesalamine, drug for further processing labeled by Patheon Manufacturing Services Llc. The product's dosage form is capsule and is administered via form.

Is NDC 63552-043 included in the NDC Directory?

Yes, Mesalamine is an UNFINISHED PRODUCT with code 63552-043 that is active and included in the NDC Directory. The product was first marketed by Patheon Manufacturing Services Llc on July 08, 2004 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 63552-043-03?

The 11-digit format is 63552004303. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-263552-043-035-4-263552-0043-03