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  5. NDC Package Code: 42799-115-01 Colestipol Hydrochloride

NDC Package 42799-115-01 Colestipol Hydrochloride

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
42799-115-01
Package Description:
120 TABLET in 1 BOTTLE
Product Code:
42799-115
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 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 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-Cholesterol mg/dL (mmol/L)Definite Atherosclerotic Disease*Two or More Other Risk Factors**Initiation LevelGoalNoNo≥190 (≥4.9) <160 (<4.1) NoYes≥160 (≥4.1) <130 (<3.4) YesYes or No≥130 (≥3.4) ≤100 (≤2.6) * Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). ** Other 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).
11-Digit NDC Billing Format:
42799011501
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:
Product Type:
Human Prescription Drug
Labeler Name:
Edenbridge Pharmaceuticals Llc.
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
COLESTIPOL HYDROCHLORIDE 1 g/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA217667
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
11-26-2024
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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.

Frequently Asked Questions

What is NDC 42799-115-01?

The NDC Packaged Code 42799-115-01 is assigned to a package of 120 tablet in 1 bottle of Colestipol Hydrochloride, a human prescription drug labeled by Edenbridge Pharmaceuticals Llc.. The product's dosage form is tablet and is administered via oral form.

Is NDC 42799-115 included in the NDC Directory?

Yes, Colestipol Hydrochloride with product code 42799-115 is active and included in the NDC Directory. The product was first marketed by Edenbridge Pharmaceuticals Llc. on November 26, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 42799-115-01?

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 42799-115-01?

The 11-digit format is 42799011501. 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 5-3-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-242799-115-015-4-242799-0115-01