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NDC 50402-0100-14 IDkit HP ONE 4; 75 g/1; mg/1 Details
IDkit HP ONE 4; 75 g/1; mg/1
IDkit HP ONE is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meridian Bioscience Israel Ltd. The primary component is CITRIC ACID MONOHYDRATE; UREA C-13.
Product Information
| NDC | 50402-0100 |
|---|---|
| Product ID | 50402-100_66171a45-4f8f-44f7-b8b0-03bec093d838 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | IDkit HP ONE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | citric acid anhydrous and 13C urea |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 4; 75 |
| Active Ingredient Units | g/1; mg/1 |
| Substance Name | CITRIC ACID MONOHYDRATE; UREA C-13 |
| Labeler Name | Meridian Bioscience Israel Ltd |
| Pharmaceutical Class | 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 |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021314 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50402-0100-14 (50402010014)
| NDC Package Code | 50402-100-14 |
|---|---|
| Billing NDC | 50402010014 |
| Package | 5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOX |
| Marketing Start Date | 2017-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |