Welchol
NDC Package 65597-902-30
Package Information
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 Daiichi Sankyo Inc., this product is identified by NDC 65597-902 and is authorized under FDA application NDA022362.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 65597 - Daiichi Sankyo Inc.
- 65597-902 - Welchol
- 65597-902-30 - 30 PACKET in 1 CARTON / 1 FOR SUSPENSION in 1 PACKET
- 65597-902 - Welchol
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 the distribution configuration for this product package?
The code 65597-902-30 identifies a specific commercial package of 30 packet in 1 carton / 1 for suspension in 1 packet of Welchol, labeled by Daiichi Sankyo Inc.. 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 Daiichi Sankyo Inc. on January 01, 2010. The current certification is valid through February 28, 2026.
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 Daiichi Sankyo Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 65597090230. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.