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  5. NDC Package Code: 0615-8550-39 Omega-3-acid Ethyl Esters

NDC Package 0615-8550-39 Omega-3-acid Ethyl Esters

Capsule, Liquid Filled 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:
0615-8550-39
Package Description:
30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code:
0615-8550
Proprietary Name:
Omega-3-acid Ethyl Esters
Non-Proprietary Name:
Omega-3-acid Ethyl Esters
Substance Name:
Omega-3-acid Ethyl Esters
Usage Information:
Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia.Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules.Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of TG-lowering drug therapy.Limitations of Use:The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined.The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.
11-Digit NDC Billing Format:
00615855039
NDC to RxNorm Crosswalk:
  • RxCUI: 577208 - omega-3 acid ethyl esters 1 GM Oral Capsule
  • RxCUI: 577208 - omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule
  • RxCUI: 577208 - omega-3 acid ethyl esters 1 GM (at least 900 MG) Oral Capsule
Product Type:
Human Prescription Drug
Labeler Name:
Ncs Healthcare Of Ky, Llc Dba Vangard Labs
Dosage Form:
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
OMEGA-3-ACID ETHYL ESTERS 1 g/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA210093
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-02-2020
Listing Expiration Date:
12-31-2025
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 0615-8550-39?

The NDC Packaged Code 0615-8550-39 is assigned to a package of 30 capsule, liquid filled in 1 blister pack of Omega-3-acid Ethyl Esters, a human prescription drug labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The product's dosage form is capsule, liquid filled and is administered via oral form.

Is NDC 0615-8550 included in the NDC Directory?

Yes, Omega-3-acid Ethyl Esters with product code 0615-8550 is active and included in the NDC Directory. The product was first marketed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs on July 02, 2020 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0615-8550-39?

The 11-digit format is 00615855039. 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 4-4-2 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
4-4-20615-8550-395-4-200615-8550-39