Colestipol Hydrochloride Tablet, Film Coated
NDC Package 0115-5211-16

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

Package Information

Colestipol Hydrochloride tablets 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 tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. This formulation utilizes a tablet, film coated delivery system. Marketed by Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 0115-5211 and is authorized under FDA application ANDA077510.

Identification & Billing

NDC Package Code
0115-5211-16
Package Description
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
0115-5211
11-Digit Billing Format
00115521116
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Colestipol Hydrochloride
Non-Proprietary Name
Colestipol Hydrochloride
Substance Name
Colestipol Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
COLESTIPOL HYDROCHLORIDE 1 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 tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Generally, colestipol tablets have no clinically significant effect on serum triglycerides, but with their 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-Cholesterol mg/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 LevelGoal 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 #
ANDA077510
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-17-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0115-5211). Click a package code to view its specific billing and regulatory data.

0115-5211-02
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 0115-5211-16 identifies a specific commercial package of 120 tablet, film coated in 1 bottle, plastic of Colestipol Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. This tablet, film coated 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 August 17, 2021. 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: 00115521116. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 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)
0115-5211-16
11-Digit CMS (5-4-2)
00115-5211-16

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