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  5. NDC Package Code: 69784-420-60 Lovaza

NDC Package 69784-420-60 Lovaza

Omega-3-acid Ethyl Esters Capsule, Liquid Filled Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
69784-420-60
Package Description:
60 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code:
69784-420
Proprietary Name:
Lovaza
Non-Proprietary Name:
Omega-3-acid Ethyl Esters
Substance Name:
Omega-3-acid Ethyl Esters
Usage Information:
Omega-3 acid ethyl esters, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of a certain blood fat (triglyceride). It may also raise "good" cholesterol (HDL). In general, this drug is used after your blood fat levels have not been fully controlled by non-drug treatments (such as diet changes, exercise, decreasing alcohol intake, weight loss if overweight, controlling blood sugar if diabetic, and regulating your thyroid hormone levels). Lowering triglycerides and increasing "good" cholesterol may help decrease the risk for strokes and heart attacks. Omega-3 acid ethyl esters are thought to work by decreasing the amount of triglyceride the body makes.
11-Digit NDC Billing Format:
69784042060
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
  • RxCUI: 607044 - Lovaza 1 GM Oral Capsule
  • RxCUI: 607044 - omega-3 acid ethyl esters (USP) 1000 MG Oral Capsule [Lovaza]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Woodward Pharma Services Llc
    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):
  • Fatty Acids, Omega-3 - [CS]
  • Omega-3 Fatty Acid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA204940
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-30-2015
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    69784-420-12120 CAPSULE, LIQUID FILLED in 1 BOTTLE
    69784-420-36360 CAPSULE, LIQUID FILLED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69784-420-60?

    The NDC Packaged Code 69784-420-60 is assigned to a package of 60 capsule, liquid filled in 1 bottle of Lovaza, a human prescription drug labeled by Woodward Pharma Services Llc. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 69784-420 included in the NDC Directory?

    Yes, Lovaza with product code 69784-420 is active and included in the NDC Directory. The product was first marketed by Woodward Pharma Services Llc on November 30, 2015 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 11-digit format for NDC 69784-420-60?

    The 11-digit format is 69784042060. 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
    5-3-269784-420-605-4-269784-0420-60