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  5. NDC Package Code: 0407-1416-12 Omnipaque

NDC Package 0407-1416-12 Omnipaque

Iohexol Solution 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:
0407-1416-12
Package Description:
10 BOTTLE, PLASTIC in 1 BOX / 500 mL in 1 BOTTLE, PLASTIC
Product Code:
0407-1416
Proprietary Name:
Omnipaque
Non-Proprietary Name:
Iohexol
Substance Name:
Iohexol
Usage Information:
This medication is used before X-ray imaging tests (such as CT scans). Iohexol contains iodine and belongs to a class of drugs known as contrast media or dyes. It works by adding contrast to body parts and fluids in these imaging tests. Iohexol improves the images obtained during a CT scan, so your doctor can more easily diagnose your condition.
11-Digit NDC Billing Format:
00407141612
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type:
Human Prescription Drug
Labeler Name:
Ge Healthcare Inc.
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • IOHEXOL 12 mg/mL
    • Pharmacologic Class(es):
  • Radiographic Contrast Agent - [EPC] (Established Pharmacologic Class)
  • X-Ray Contrast Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA018956
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-27-2018
    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.

    Frequently Asked Questions

    What is NDC 0407-1416-12?

    The NDC Packaged Code 0407-1416-12 is assigned to a package of 10 bottle, plastic in 1 box / 500 ml in 1 bottle, plastic of Omnipaque, a human prescription drug labeled by Ge Healthcare Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 0407-1416 included in the NDC Directory?

    Yes, Omnipaque with product code 0407-1416 is active and included in the NDC Directory. The product was first marketed by Ge Healthcare Inc. on April 27, 2018 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 0407-1416-12?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0407-1416-12?

    The 11-digit format is 00407141612. 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
    4-4-20407-1416-125-4-200407-1416-12