| Product NDC: | 50402-100 |
| Proprietary Name: | IDkit HP ONE |
| Non Proprietary Name: | citric acid anhydrous and 13C urea |
| Active Ingredient(s): | & nbsp; citric acid anhydrous and 13C urea |
| Administration Route(s): | ORAL |
| Dosage Form(s): | KIT |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50402-100 |
| Labeler Name: | Exalenz Bioscience Ltd. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021314 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20091228 |
| Package NDC: | 50402-100-11 |
| Package Description: | 25 BAG in 1 CASE (50402-100-11) > 1 KIT in 1 BAG (50402-100-01) * 1 POWDER, FOR SOLUTION in 1 PACKET |
| NDC Code | 50402-100-11 |
| Proprietary Name | IDkit HP ONE |
| Package Description | 25 BAG in 1 CASE (50402-100-11) > 1 KIT in 1 BAG (50402-100-01) * 1 POWDER, FOR SOLUTION in 1 PACKET |
| Product NDC | 50402-100 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | citric acid anhydrous and 13C urea |
| Dosage Form Name | KIT |
| Route Name | ORAL |
| Start Marketing Date | 20091228 |
| Marketing Category Name | NDA |
| Labeler Name | Exalenz Bioscience Ltd. |
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