Idkit Hp One Solution
NDC Package 50402-100-13

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Idkit Hp One (citric acid anhydrous and 13c urea) solution is classified as a

administered via oral route. This formulation utilizes a solution delivery system. Marketed by Meridian Bioscience Israel Ltd, this product is identified by NDC 50402-100 and is authorized under FDA application NDA021314.

Identification & Billing

NDC Package Code
50402-100-13
Package Description
25 BAG in 1 BOX / 1 SOLUTION in 1 BAG
Product Code
50402-100
11-Digit Billing Format
50402010013

Clinical Specifications

Proprietary Name
Idkit Hp One
Non-Proprietary Name
Citric Acid Anhydrous And 13c Urea
Substance Name
Citric Acid Monohydrate; Urea C-13
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Meridian Bioscience Israel Ltd
Product Type
Human Prescription Drug
FDA Application #
NDA021314
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-28-2009
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50402-100). Click a package code to view its specific billing and regulatory data.

50402-100-14
5 BOX in 1 CASE / 1 SOLUTION in 1 BOX

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50402-100-13 identifies a specific commercial package of 25 bag in 1 box / 1 solution in 1 bag of Idkit Hp One, a human prescription drug labeled by Meridian Bioscience Israel Ltd. This solution is formulated for oral use and contains citric acid monohydrate; urea c-13 as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Meridian Bioscience Israel Ltd on December 28, 2009. The current certification is valid through December 31, 2026.

How is this Meridian Bioscience Israel Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50402010013. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50402-100-13
11-Digit CMS (5-4-2)
50402-0100-13

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.