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  5. NDC Package Code: 43598-230-18 Colesevelam Hydrochloride

NDC Package 43598-230-18 Colesevelam 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:
43598-230-18
Package Description:
180 TABLET in 1 BOTTLE
Product Code:
43598-230
Proprietary Name:
Colesevelam Hydrochloride
Non-Proprietary Name:
Colesevelam Hydrochloride
Substance Name:
Colesevelam Hydrochloride
Usage Information:
Colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with a hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin).   Colesevelam hydrochloride tablets are indicated as monotherapy or in combination with a statin to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:   a. LDL-C remains ≥ 190 mg/dL or b. LDL-C remains ≥ 160 mg/dL and • there is a positive family history of premature cardiovascular disease or • two or more other CVD risk factors are present in the pediatric patient.   Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate [See Clinical Studies (14.1)].   In patients with coronary heart disease (CHD) or CHD risk equivalents such as diabetes mellitus, LDL-C treatment goals are <100 mg/dL. An LDL-C goal of <70 mg/dL is a therapeutic option on the basis of recent trial evidence. If LDL-C is at goal but the serum triglyceride (TG) value is >200 mg/dL, then non-HDL cholesterol (non-HDL-C) (total cholesterol [TC] minus high density lipoprotein cholesterol [HDL-C]) becomes a secondary target of therapy. The goal for non-HDL-C in persons with high serum TG is set at 30 mg/dL higher than that for LDL-C.
11-Digit NDC Billing Format:
43598023018
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
180 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 866910 - colesevelam HCl 625 MG Oral Tablet
  • RxCUI: 866910 - colesevelam hydrochloride 625 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dr.reddys Laboratories Inc
    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):
  • COLESEVELAM HYDROCHLORIDE 625 mg/1
    • Pharmacologic Class(es):
  • Bile Acid Sequestrant - [EPC] (Established Pharmacologic Class)
  • Bile-acid Binding Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA210889
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-05-2018
    Listing Expiration Date:
    12-31-2024
    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 43598-230-18?

    The NDC Packaged Code 43598-230-18 is assigned to a package of 180 tablet in 1 bottle of Colesevelam Hydrochloride, a human prescription drug labeled by Dr.reddys Laboratories Inc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 43598-230 included in the NDC Directory?

    Yes, Colesevelam Hydrochloride with product code 43598-230 is active and included in the NDC Directory. The product was first marketed by Dr.reddys Laboratories Inc on October 05, 2018 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 43598-230-18?

    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 180.

    What is the 11-digit format for NDC 43598-230-18?

    The 11-digit format is 43598023018. 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
    5-3-243598-230-185-4-243598-0230-18