NDC Package 59762-0260-3 Colestipol Hydrochloride

Granule, For Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

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Frequently Asked Questions

Package Information

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:

59762-0260-3

Package Description:

500 g in 1 BOTTLE

Product Code:

59762-0260

Proprietary Name:

Colestipol Hydrochloride

Non-Proprietary Name:

Colestipol Hydrochloride

Substance 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.Colestipol hydrochloride granules are 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 granules have 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 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; 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 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:

59762026003

Billing Unit:

GM - Billing unit of "gram" is used when a product is measured by its weight.

NDC to RxNorm Crosswalk:

500 GM

NDC to 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

Product Type:

Human Prescription Drug

Labeler Name:

Greenstone Llc

Dosage Form:

Granule, For Suspension - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

COLESTIPOL HYDROCHLORIDE 5 g/5g

Pharmacologic Class(es):

Bile Acid Sequestrant - [EPC] (Established Pharmacologic Class)

Bile-acid Binding Activity - [MoA] (Mechanism of Action)

Sample Package:

FDA Application Number:

NDA017563

Marketing Category:

NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

Start Marketing Date:

04-04-1977

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

59762 - Greenstone Llc
- 59762-0260 - Colestipol Hydrochloride
  - 59762-0260-3 - 500 g 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
59762-0260-1	30 PACKET in 1 CARTON / 5 g in 1 PACKET
59762-0260-2	90 PACKET in 1 CARTON / 5 g in 1 PACKET

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 59762-0260-3?

The NDC Packaged Code 59762-0260-3 is assigned to a package of 500 g in 1 bottle of Colestipol Hydrochloride, a human prescription drug labeled by Greenstone Llc. The product's dosage form is granule, for suspension and is administered via oral form.

Is NDC 59762-0260 included in the NDC Directory?

Yes, Colestipol Hydrochloride with product code 59762-0260 is active and included in the NDC Directory. The product was first marketed by Greenstone Llc on April 04, 1977 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 59762-0260-3?

The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 500.

What is the 11-digit format for NDC 59762-0260-3?

The 11-digit format is 59762026003. 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	59762-0260-3	5-4-2	59762-0260-03

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