Colesevelam Hydrochloride Tablet
NDC Package 69452-493-25

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

Package Information

Colesevelam Hydrochloride tablets is colesevelam hydrochloride is contraindicated in patients with:Serum TG concentrations > 500 mg/dL [see Warnings and Precautions (5.1)] History of hypertriglyceridemia-induced pancreatitis [see Warnings and Precautions (5.1)] A history of bowel obstruction [see Warnings and Precautions (5.2)]. This formulation utilizes a tablet delivery system. Marketed by Bionpharma Inc., this product is identified by NDC 69452-493 and is authorized under FDA application ANDA208670.

Identification & Billing

NDC Package Code
69452-493-25
Package Description
180 TABLET in 1 BOTTLE
Product Code
69452-493
11-Digit Billing Format
69452049325
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Colesevelam Hydrochloride
Non-Proprietary Name
Colesevelam Hydrochloride
Substance Name
Colesevelam Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
COLESEVELAM HYDROCHLORIDE 625 mg/1
Pharmacologic Class
Usage Information
Colesevelam hydrochloride is contraindicated in patients with:Serum TG concentrations > 500 mg/dL [see Warnings and Precautions (5.1)] History of hypertriglyceridemia-induced pancreatitis [see Warnings and Precautions (5.1)] A history of bowel obstruction [see Warnings and Precautions (5.2)]

Regulatory & Marketing

Labeler Name
Bionpharma Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208670
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-12-2026
Listing Expiration
12-31-2027
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 69452-493-25 identifies a specific commercial package of 180 tablet in 1 bottle of Colesevelam Hydrochloride, a human prescription drug labeled by Bionpharma Inc.. This tablet 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 Bionpharma Inc. on February 12, 2026. The current certification is valid through December 31, 2027.

How is this Bionpharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69452049325. 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)
69452-493-25
11-Digit CMS (5-4-2)
69452-0493-25

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