IDkit HP ONE
- Product NDC
- 50402-100
- 11-digit product format
- 504020100
- Labeler code
- 50402
- Product ID
- 50402-100_14276165-5001-4e53-a474-d7cf6931f051
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- citric acid anhydrous and 13C urea
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Meridian Bioscience Israel Ltd
- Application
- NDA021314
- Marketing category
- NDA
- Marketing start
- 2009-12-28
- Substance
- CITRIC ACID MONOHYDRATE; UREA C-13
- Active strength
- 4; 75 g/1; mg/1
- Pharmacologic 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IDkit HP ONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CITRIC ACID MONOHYDRATE | 4 g/1 |
| UREA C-13 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2968PHW8QP, W6KX9E6D8X |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50402-100-13 | IDkit HP ONE | 25 in 1 BOX | SOLUTION | 25 | | 5 |
| 50402-100-13 | IDkit HP ONE | 1 in 1 BAG | SOLUTION | 1 | | 5 |
| 50402-100-14 | IDkit HP ONE | 5 in 1 CASE | SOLUTION | 5 | | 5 |
| 50402-100-14 | IDkit HP ONE | 1 in 1 BOX | SOLUTION | 1 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50402-100 | IDKIT HP ONE (CITRIC ACID ANHYDROUS AND 13C UREA) SOLUTION [MERIDIAN BIOSCIENCE ISRAEL LTD] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250131_8baab7a7-5d20-46ad-9c4a-762992ef6b51.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50402-100-13 | 50402010013 | 25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAG | 25 bag | 2013-05-01 | 0000-00-00 | No | No | Current |
| 50402-100-14 | 50402010014 | 5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOX | 5 box | 2017-01-01 | 0000-00-00 | No | No | Current |