NDC Package 54868-0610-0 Colestipol Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

54868-0610-0

Package Description:

120 TABLET in 1 BOTTLE

Product Code:

54868-0610

Proprietary Name:

Colestipol Hydrochloride

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.Micronized colestipol hydrochloride 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, micronized colestipol hydrochloride 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-Cholesterolmg/dL (mmol/L)Definite Atherosclerotic 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; female: ≥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 LevelGoalNoNo≥190(≥4.9)<160(<4.1)NoYes≥160(≥4.1)<130(<3.4)YesYes or No≥130(≥3.4)≤100(≤2.6)

11-Digit NDC Billing Format:

54868061000

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

120 EA

NDC to RxNorm Crosswalk:

RxCUI: 1048445 - colestipol HCl 1 GM Oral Tablet

RxCUI: 1048445 - colestipol hydrochloride 1000 MG Oral Tablet

RxCUI: 1048445 - colestipol hydrochloride 1 GM Oral Tablet

Labeler Name:

Physicians Total Care, Inc.

Sample Package:

Start Marketing Date:

02-28-2007

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

54868 - Physicians Total Care, Inc.
- 54868-0610 - Colestipol Hydrochloride
  - 54868-0610-0 - 120 TABLET in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
54868-0610-1	30 TABLET in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 54868-0610-0?

The NDC Packaged Code 54868-0610-0 is assigned to a package of 120 tablet in 1 bottle of Colestipol Hydrochloride, labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package.

Is NDC 54868-0610 included in the NDC Directory?

No, Colestipol Hydrochloride with product code 54868-0610 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Physicians Total Care, Inc. on February 28, 2007 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 54868-0610-0?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 120.

What is the 11-digit format for NDC 54868-0610-0?

The 11-digit format is 54868061000. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	54868-0610-0	5-4-2	54868-0610-00

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