Welchol
NDC Package 51138-580-30

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

Package Information

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

Welchol is a medication used along with a proper diet and exercise to lower cholesterol in people with high levels of cholesterol in the blood. Marketed by Med-health Pharma, Llc, this product is identified by NDC 51138-580 and is authorized under FDA application NDA021176.

Identification & Billing

NDC Package Code
51138-580-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
51138-580
11-Digit Billing Format
51138058030

Clinical Specifications

Proprietary Name
Welchol
Dosage Form
-
Usage Information
This medication is used along with a proper diet and exercise to lower cholesterol in people with high levels of cholesterol in the blood. Lowering cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. Colesevelam is also used along with a proper diet and exercise to lower high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Colesevelam belongs to a class of drugs called bile acid-binding resins. Bile acid is a natural substance the liver makes by using cholesterol. This medication works by removing bile acid from the body. This causes the liver to make more bile acid by using cholesterol, which reduces cholesterol levels in the blood. It is not known how colesevelam works in lowering blood sugar.

Regulatory & Marketing

Labeler Name
Med-health Pharma, Llc
FDA Application #
NDA021176
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-15-2011
End Marketing Date
08-01-2012
Listing Expiration
08-01-2012
Exclude Flag
D
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 51138-580-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Welchol, labeled by Med-health Pharma, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Med-health Pharma, Llc on July 15, 2011. The current certification is valid through August 01, 2012.

What are the primary indications for this medication?

This medication is used along with a proper diet and exercise to lower cholesterol in people with high levels of cholesterol in the blood. Lowering cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. Colesevelam is also used along with a proper diet and exercise to lower high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Colesevelam belongs to a class of drugs called bile acid-binding resins. Bile acid is a natural substance the liver makes by using cholesterol. This medication works by removing bile acid from the body. This causes the liver to make more bile acid by using cholesterol, which reduces cholesterol levels in the blood. It is not known how colesevelam works in lowering blood sugar.

How is this Med-health Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51138058030. 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 (5-3-2)
51138-580-30
11-Digit CMS (5-4-2)
51138-0580-30

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