Colestipol Hydrochloride Suspension
NDC Package 0115-5213-02

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

Package Information

Colestipol Hydrochloride suspension is since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use.Colestipol hydrochloride for oral suspension, USP is indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [LDL] cholesterol) who do not respond adequately to diet. This formulation utilizes a suspension delivery system. Marketed by Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 0115-5213 and is authorized under FDA application ANDA077277.

Identification & Billing

NDC Package Code
0115-5213-02
Package Description
100 SUSPENSION in 1 BOTTLE
Product Code
0115-5213
11-Digit Billing Format
00115521302
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk
  • RxCUI: 1048450 - colestipol HCl 5 GM Granules For Oral Suspension
  • RxCUI: 1048450 - colestipol hydrochloride 5000 MG Granules for Oral Suspension
  • RxCUI: 1048450 - colestipol hydrochloride 5 GM Granules For Oral Suspension

Clinical Specifications

Proprietary Name
Colestipol Hydrochloride
Non-Proprietary Name
Colestipol Hydrochloride
Substance Name
Colestipol Hydrochloride
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
COLESTIPOL HYDROCHLORIDE 5 g/1
Pharmacologic Class
Usage Information
Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use.Colestipol hydrochloride for oral suspension, USP is indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [LDL] cholesterol) who do not respond adequately to diet. Generally, colestipol hydrochloride for oral suspension, USP has no clinically significant effect on serum triglycerides, but with its use triglyceride levels may be raised in some patients.Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy (see NCEP guidelines). A minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. Shorter periods may be considered in patients with severe elevations of LDL-C or with definite CHD.According to the NCEP guidelines, the goal of treatment is to lower LDL-C, and LDL-C is to be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy. The NCEP treatment guidelines are shown below. LDL-Cholesterolmg/dL (mmol/L) Definite Atheroschlerotic DiseaseCoronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). Two or More Other Risk FactorsOther risk factors for coronary heart disease (CHD) include: age (males: ≥45 years; females: ≥55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is ≥60 mg/dL (1.6 mmol/L). Initiation Level Goal No No ≥190(≥4.9) <160(<4.1) No Yes ≥160(≥4.1) <130(<3.4) Yes Yes or No ≥130(≥3.4) ≤100(≤2.6)

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Of New York Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA077277
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-02-2006
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 0115-5213-02 identifies a specific commercial package of 100 suspension in 1 bottle of Colestipol Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. This suspension is formulated for oral use and contains colestipol 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 May 02, 2006. 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: 00115521302. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
0115-5213-02
11-Digit CMS (5-4-2)
00115-5213-02

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