Medicine
IDkit HP ONE 4 g/75 mg oral solution
IDkit HP ONE 4 g/75 mg oral solution is a prescription medicine containing Citric acid and Urea c-13 for oral use, marketed by Meridian Bioscience Israel, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F…
Key facts
- Active ingredient (INN)
- Citric acid and Urea c-13
- Brand
- IDkit HP ONE
- Strength
- 4 g/75 mg
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 25 bags, 5 boxes
- Marketing authorisation holder
- Meridian Bioscience Israel
- Manufacturer
- Meridian Bioscience Israel
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 December 2009
- Identifiers
- DailyMed set ID 8baab7a7-5d20-46ad-9c4a-762992ef6b51NDC 50402-100Application NDA021314
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 bag in 1 box / 1 solution in 1 bag | 50402-100-13 | Meridian Bioscience Israel | 1 May 2013 |
| 5 box in 1 case / 1 solution in 1 box | 50402-100-14 | Meridian Bioscience Israel | 1 January 2017 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 17 December 2002 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Citric acid and Urea c-13 is a fixed-dose combination of an anti-coagulant, a calculi dissolution agent and a helicobacter pylori diagnostic. It is available as oral solution. MedsAcross supplies Citric acid and Urea c-13 for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Citric acid and Urea c-13For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- IDkit HP ONE prescribing information (Meridian Bioscience Israel) · U.S. National Library of Medicine, DailyMed
Need IDkit HP ONE 4 g/75 mg oral solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.