What is NDC 50402-100?

50402-100 is the product NDC for IDkit HP ONE, Urea c-13 75 mg/1; Citric acid monohydrate 4 g/1 solution, listed with the FDA by Meridian Bioscience Israel Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

IDkit HP ONE (Citric acid anhydrous and 13C urea).

What is the active ingredient?

Urea c-13, Citric acid monohydrate.

Meridian Bioscience Israel Ltd, NDC labeler code 50402. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for IDkit HP ONE?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

IDkit HP ONE NDC 50402-100 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50402-100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50402-0100Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50402-100-13	5040201001350402010013	25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAGMarketed from May 1, 2013
50402-100-14	5040201001450402010014	5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOXMarketed from Jan 1, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): IDkit HP ONE
Generic name (nonproprietary): citric acid anhydrous and 13c urea
Active ingredients: Urea c-13 — 75 mg/1Citric acid monohydrate — 4 g/1
Dosage form: Solution
Route: Oral
Labeler: Meridian Bioscience Israel LtdNDC labeler code 50402
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021314
Marketing start: Dec 28, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Carbon Radioisotopes (Chemical structure)Decreased Coagulation Factor Activity (Physiologic effect)Radioactive Tracers (Chemical structure)Urea (Chemical structure)
Identifiers: Product ID 50402-100_76ea9288-076c-4e3b-930c-5653181aaaefSPL ID 76ea9288-076c-4e3b-930c-5653181aaaefSPL set ID 8baab7a7-5d20-46ad-9c4a-762992ef6b51UNII W6KX9E6D8X, 2968PHW8QP
Pharmacologic class: Anti-coagulant; Calculi Dissolution Agent; Helicobacter pylori Diagnostic

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450402010013 followed by a unit qualifier and the quantity

Package 50402-0100-13. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 28, 2026.

Indications (excerpt from the label)

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. 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. ( 1 ) IDkit Hp …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50402-100

What is NDC 50402-100?: 50402-100 is the product NDC for IDkit HP ONE, Urea c-13 75 mg/1; Citric acid monohydrate 4 g/1 solution, listed with the FDA by Meridian Bioscience Israel Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: IDkit HP ONE (Citric acid anhydrous and 13C urea).
What is the active ingredient?: Urea c-13, Citric acid monohydrate.
Who is the labeler?: Meridian Bioscience Israel Ltd, NDC labeler code 50402. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for IDkit HP ONE?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

IDkit HP ONE (Citric acid anhydrous and 13c urea) NDC 50402-100