Prescription medicine
Citric acid and urea c 13 Brand names: Idkit; first approved as Idkit:Hp
Citric acid and urea c 13 (Idkit) is a prescription medicine with an FDA approval on record since 2002. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the citric acid and urea c 13 FDA label on DailyMed (effective July 28, 2026, Meridian Bioscience Israel Ltd); the NDA 21314 record on Drugs@FDA; every citric acid and urea c 13 label on DailyMed.
Highlights of the record
FDA label of July 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIDkit 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.
Forms and strengths
- 75 mg / 4 g
Solution.
On the market
- Earliest approval on file
- December 17, 2002 Idkit:Hp, Meridian Bioscience; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is citric acid and urea c 13 used for?
From the label: indications and usageIDkit 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. 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. […]
FDA pharmacologic class: Anti-coagulant, Calculi Dissolution Agent and Helicobacter pylori Diagnostic.
Source: FDA drug label (IDkit HP ONE), Meridian Bioscience Israel Ltd, effective July 28, 2026 (SPL set 8baab7a7-5d20-46ad-9c4a-762992ef6b51), via openFDA; the full label on DailyMed
Is there a generic for citric acid and urea c 13 (Idkit)?
No generic citric acid and urea c 13 is approved (Drugs@FDA, October 8, 2026).
- 2002 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What next?
- Other anti-coagulants
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other