Colesevelam Hydrochloride For Suspension
NDC Package 0115-1864-18

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

Package Information

Colesevelam Hydrochloride for suspensions is colesevelam hydrochloride for oral suspension 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 for suspension delivery system. Marketed by Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 0115-1864 and is authorized under FDA application ANDA212886.

Identification & Billing

NDC Package Code
0115-1864-18
Package Description
30 PACKET in 1 CARTON / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30)
Product Code
0115-1864
11-Digit Billing Format
00115186418
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
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
Colesevelam hydrochloride for oral suspension 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
Amneal Pharmaceuticals Of New York Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212886
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-20-2023
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 0115-1864-18 identifies a specific commercial package of 30 packet in 1 carton / 1 for suspension in 1 packet (0115-1864-30) of Colesevelam Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. 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 Amneal Pharmaceuticals Of New York Llc on January 20, 2023. The current certification is valid through December 31, 2026.

How is this Amneal Pharmaceuticals Of New York Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00115186418. 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)
0115-1864-18
11-Digit CMS (5-4-2)
00115-1864-18

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