Colesevelam Hydrochloride Powder, For Suspension
NDC Package 68462-620-30

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

Package Information

Colesevelam Hydrochloride powders is colesevelam hydrochloride is contraindicated in patients with•A history of bowel obstruction [See Warnings and Precautions (5.4)]•Serum TG concentrations >500 mg/dL [See Warnings and Precautions (5.2)]•A history of hypertriglyceridemia-induced pancreatitis [See Warnings and Precautions (5.2)]. This formulation utilizes a powder, for suspension delivery system. Marketed by Glenmark Pharmaceuticals Inc.,usa, this product is identified by NDC 68462-620 and is authorized under FDA application ANDA202190.

Identification & Billing

NDC Package Code
68462-620-30
Package Description
30 PACKET in 1 BOX / 1 POWDER, FOR SUSPENSION in 1 PACKET
Product Code
68462-620
11-Digit Billing Format
68462062030
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

Clinical Specifications

Proprietary Name
Colesevelam Hydrochloride
Non-Proprietary Name
Colesevelam Hydrochloride
Substance Name
Colesevelam Hydrochloride
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
COLESEVELAM HYDROCHLORIDE 3.75 g/1
Pharmacologic Class
Usage Information
Colesevelam hydrochloride is contraindicated in patients with•A history of bowel obstruction [See Warnings and Precautions (5.4)]•Serum TG concentrations >500 mg/dL [See Warnings and Precautions (5.2)]•A history of hypertriglyceridemia-induced pancreatitis [See Warnings and Precautions (5.2)]

Regulatory & Marketing

Labeler Name
Glenmark Pharmaceuticals Inc.,usa
Product Type
Human Prescription Drug
FDA Application #
ANDA202190
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-16-2018
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 68462-620-30 identifies a specific commercial package of 30 packet in 1 box / 1 powder, for suspension in 1 packet of Colesevelam Hydrochloride, a human prescription drug labeled by Glenmark Pharmaceuticals Inc.,usa. This powder, 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 Glenmark Pharmaceuticals Inc.,usa on July 16, 2018. The current certification is valid through December 31, 2027.

How is this Glenmark Pharmaceuticals Inc.,usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68462062030. 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 (5-3-2)
68462-620-30
11-Digit CMS (5-4-2)
68462-0620-30

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