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  5. NDC Package Code: 50402-100-14 Idkit Hp One

NDC Package 50402-100-14 Idkit Hp One

Citric Acid Anhydrous And 13c Urea Solution 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:
50402-100-14
Package Description:
5 BOX in 1 CASE / 1 SOLUTION in 1 BOX
Product Code:
50402-100
Proprietary Name:
Idkit Hp One
Non-Proprietary Name:
Citric Acid Anhydrous And 13c Urea
Substance Name:
Citric Acid Monohydrate; Urea C-13
11-Digit NDC Billing Format:
50402010014
Product Type:
Human Prescription Drug
Labeler Name:
Meridian Bioscience Israel Ltd
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):
  • CITRIC ACID MONOHYDRATE 4 g/1
  • UREA C-13 75 mg/1
    • Pharmacologic Class(es):
  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Carbon Radioisotopes - [CS]
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Helicobacter pylori Diagnostic - [EPC] (Established Pharmacologic Class)
  • Radioactive Tracers - [CS]
  • Urea - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA021314
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-28-2009
    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
    50402-100-1325 BAG in 1 BOX / 1 SOLUTION in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50402-100-14?

    The NDC Packaged Code 50402-100-14 is assigned to a package of 5 box in 1 case / 1 solution in 1 box of Idkit Hp One, a human prescription drug labeled by Meridian Bioscience Israel Ltd. The product's dosage form is solution and is administered via oral form.

    Is NDC 50402-100 included in the NDC Directory?

    Yes, Idkit Hp One with product code 50402-100 is active and included in the NDC Directory. The product was first marketed by Meridian Bioscience Israel Ltd on December 28, 2009 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 50402-100-14?

    The 11-digit format is 50402010014. 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
    5-3-250402-100-145-4-250402-0100-14