NDC Package 43598-267-04 Icosapent

Icosapent Ethyl Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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:

43598-267-04

Package Description:

120 CAPSULE in 1 BOTTLE

Product Code:

43598-267

Proprietary Name:

Icosapent

Non-Proprietary Name:

Icosapent Ethyl

Substance Name:

Icosapent Ethyl

Usage Information:

Icosapent ethyl is used along with certain other cholesterol medications ("statins" such as atorvastatin, simvastatin) to reduce the risk of heart attack, stroke, and certain types of heart problems that require treatment in a hospital. It is also used along with a proper diet to help lower fats (triglycerides) in the blood. Icosapent ethyl is a type of omega-3 fatty acid, a fat found in fish oil. It is thought to work by decreasing the amount of triglycerides made by the body. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

11-Digit NDC Billing Format:

43598026704

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: 1304979 - icosapent ethyl 1 GM Oral Capsule

RxCUI: 1304979 - icosapent ethyl 1000 MG Oral Capsule

Product Type:

Human Prescription Drug

Labeler Name:

Dr. Reddy's Laboratories, Inc.

Dosage Form:

Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

ICOSAPENT ETHYL 1000 mg/1

Sample Package:

FDA Application Number:

ANDA209499

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

06-21-2021

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

43598 - Dr. Reddy's Laboratories, Inc.
- 43598-267 - Icosapent
  - 43598-267-04 - 120 CAPSULE 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.

Frequently Asked Questions

What is NDC 43598-267-04?

The NDC Packaged Code 43598-267-04 is assigned to a package of 120 capsule in 1 bottle of Icosapent, a human prescription drug labeled by Dr. Reddy's Laboratories, Inc.. The product's dosage form is capsule and is administered via oral form.

Is NDC 43598-267 included in the NDC Directory?

Yes, Icosapent with product code 43598-267 is active and included in the NDC Directory. The product was first marketed by Dr. Reddy's Laboratories, Inc. on June 21, 2021 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 43598-267-04?

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 43598-267-04?

The 11-digit format is 43598026704. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	43598-267-04	5-4-2	43598-0267-04

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