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  5. NDC Package Code: 64380-761-11 Omega-3-acid Ethyl Esters

NDC Package 64380-761-11 Omega-3-acid Ethyl Esters

Capsule 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:
64380-761-11
Package Description:
120 CAPSULE in 1 BOTTLE
Product Code:
64380-761
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, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG).Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP.Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting  therapy with omega-3-acid ethyl esters. 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 triglyceride-lowering drug therapy.Limitations of Use: The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined.The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.
11-Digit NDC Billing Format:
64380076111
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: 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:
    Strides Pharma Science Limited
    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):
  • OMEGA-3-ACID ETHYL ESTERS 900 mg/1
    • Pharmacologic Class(es):
  • Fatty Acids, Omega-3 - [CS]
  • Omega-3 Fatty Acid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA203893
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-18-2019
    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
    64380-761-025 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK (64380-761-01)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 64380-761-11?

    The NDC Packaged Code 64380-761-11 is assigned to a package of 120 capsule in 1 bottle of Omega-3-acid Ethyl Esters, a human prescription drug labeled by Strides Pharma Science Limited. The product's dosage form is capsule and is administered via oral form.

    Is NDC 64380-761 included in the NDC Directory?

    Yes, Omega-3-acid Ethyl Esters with product code 64380-761 is active and included in the NDC Directory. The product was first marketed by Strides Pharma Science Limited on January 18, 2019 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 64380-761-11?

    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 64380-761-11?

    The 11-digit format is 64380076111. 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
    5-3-264380-761-115-4-264380-0761-11