NDC 50402-100-14 HUMAN PRESCRIPTION DRUG

Drug Status:  Active

Proprietary Name: Idkit Hp One

Drug Overview

The NDC Code 50402-100-14 is assigned to “Idkit Hp One ” (also known as: “Citric Acid Anhydrous And 13c Urea”), a human prescription drug labeled by “Meridian Bioscience Israel Ltd”. The product's dosage form is solution, and is administered via oral form.

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Drug Information
NDC Package Code	50402-100-14
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product NDC	50402-100
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
11 Digit NDC Code	50402-0100-14
	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Proprietary Name	Idkit Hp One
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Citric Acid Anhydrous And 13c Urea
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	HUMAN PRESCRIPTION DRUG
	Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Labeler Name	Meridian Bioscience Israel Ltd
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Active
	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
Description	IDkit Hp One and IDkit Hp Two are a diagnostic aid that analyzes a breath sample before and after ingestion of 13C-urea and citric acid; it is used to identify those patients with a H. pylori infection. The kit consists of a 13C-urea tablet for oral solution and Citrica (citric acid) for oral solution along with other materials for use with the BreathID system device [see How Supplied/Storage and Handling (16)]. 13C-Urea Tablet for Oral Solution. 13C-urea has a molecular weight of 61.06 g/mol and the molecular formula 13CH4N2O and the following structure. 13C-urea tablet for oral solution contains 75 mg 13C-urea and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, povidone, and sodium benzoate. Citrica (citric acid) for Oral Solution. Citric acid has a molecular weight of 210.14 g/mol and the molecular formula C6H8O7. Each pouch contains 4 g of citric acid and the following inactive ingredients: aspartame and tutti frutti flavoring.
	General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Indication And Usage	IDkit Hp® One and IDkit Hp® Two are indicated for use as a diagnostic aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori (H. pylori) infection in adults and pediatric patients 3 years of age and older. IDkit Hp One and IDkit Hp Two are to be administered only by trained personnel as ordered by a licensed healthcare practitioner using the BreathID® system device as identified in the BreathID® system device labeling.
	A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.

Route & Dosage
Dosage Form Name	SOLUTION
	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	ORAL
	The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Pharmaceutical Classes	ACIDIFYING ACTIVITY [MOA], ANTI-COAGULANT [EPC], CALCIUM CHELATING ACTIVITY [MOA], CALCULI DISSOLUTION AGENT [EPC], CARBON RADIOISOTOPES [CS], DECREASED COAGULATION FACTOR ACTIVITY [PE], HELICOBACTER PYLORI DIAGNOSTIC [EPC], RADIOACTIVE TRACERS [CS], UREA [CS]
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	UREA C-13 - 4 g/1 CITRIC ACID MONOHYDRATE (Substance Adverse Reports) - 75 mg/1
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	50402-100-14
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	5 BOX IN 1 CASE (50402-100-14) / 1 SOLUTION IN 1 BOX
	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Sample Package	N
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N
	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Package Start Marketing Date	20170101
	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package End Marketing Date	N/S (NOT SPECIFIED)
	This is the date the package will no longer be available on the market. If a package is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information
Product NDC	50402-100
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Application Number	NDA021314
	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category Name	NDA
	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Listing Record Certified Through	20271231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20091228
	This is the date that the labeler indicates was the start of its marketing of the drug product.
Product Marketing End Date	N/S (NOT SPECIFIED)
	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Product NDC Exclude Flag	N
	This indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

Tracking Information
Last Update Date	2026-08-08
	The date that a record was last updated or changed.