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  5. NDC Package Code: 70036-015-01 Omega-3 Well Pack

NDC Package 70036-015-01 Omega-3 Well Pack

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
70036-015-01
Package Description:
1 KIT in 1 BOX * 60 CAPSULE in 1 CAPSULE * 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (60505-3170-7)
Product Code:
70036-015
Proprietary Name:
Omega-3 Well Pack
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: Sections or subsections omitted from the full prescribing information are not listed. 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:
70036001501
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
Labeler Name:
Cloverleaf Pharma Llc
Sample Package:
No
FDA Application Number:
ANDA090973
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
09-01-2015
Listing Expiration Date:
12-31-2021
Exclude Flag:
I
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 70036-015-01?

The NDC Packaged Code 70036-015-01 is assigned to a package of 1 kit in 1 box * 60 capsule in 1 capsule * 120 capsule, liquid filled in 1 bottle (60505-3170-7) of Omega-3 Well Pack, labeled by Cloverleaf Pharma Llc. The product's dosage form is and is administered via form.

Is NDC 70036-015 included in the NDC Directory?

No, Omega-3 Well Pack with product code 70036-015 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Cloverleaf Pharma Llc on September 01, 2015 and its listing in the NDC Directory is set to expire on December 31, 2021 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 70036-015-01?

The 11-digit format is 70036001501. 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
5-3-270036-015-015-4-270036-0015-01