Welchol For Suspension
NDC Package 0713-0880-30

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

Package Information

Welchol (colesevelam hydrochloride) for suspensions is a medication used along with a proper diet and exercise to lower cholesterol in people with high levels of cholesterol in the blood. This formulation utilizes a for suspension delivery system. Marketed by Cosette Pharmaceuticals, Inc., this product is identified by NDC 0713-0880 and is authorized under FDA application NDA022362.

Identification & Billing

NDC Package Code
0713-0880-30
Package Description
30 PACKET in 1 CARTON / 1 FOR SUSPENSION in 1 PACKET
Product Code
0713-0880
11-Digit Billing Format
00713088030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 866905 - colesevelam HCl 3.75 GM Powder for Oral Suspension
  • RxCUI: 866905 - colesevelam hydrochloride 3750 MG Powder for Oral Suspension
  • RxCUI: 866907 - Welchol 3.75 GM Powder for Oral Suspension
  • RxCUI: 866907 - colesevelam hydrochloride 3750 MG Powder for Oral Suspension [Welchol]
  • RxCUI: 866907 - Welchol 3750 MG Powder for Oral Suspension

Clinical Specifications

Proprietary Name
Welchol
Non-Proprietary Name
Colesevelam Hydrochloride
Substance Name
Colesevelam Hydrochloride
Dosage Form
For Suspension - A product, usually a solid, intended for suspension prior to administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
COLESEVELAM HYDROCHLORIDE 3.75 g/1
Pharmacologic Class
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
Cosette Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022362
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2022
Listing Expiration
12-31-2026
Exclude Flag
N
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 0713-0880-30 identifies a specific commercial package of 30 packet in 1 carton / 1 for suspension in 1 packet of Welchol, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This for suspension is formulated for oral use and contains colesevelam hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Cosette Pharmaceuticals, Inc. on September 01, 2022. The current certification is valid through December 31, 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 Cosette Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00713088030. 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:

10-Digit Format (4-4-2)
0713-0880-30
11-Digit CMS (5-4-2)
00713-0880-30

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