| Product NDC: | 59148-023 |
| Proprietary Name: | Pranactin-Citric |
| Non Proprietary Name: | UREA C-13 |
| Active Ingredient(s): | 75 mg/3000mg & nbsp; UREA C-13 |
| Administration Route(s): | ORAL |
| Dosage Form(s): | POWDER, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 59148-023 |
| Labeler Name: | Otsuka America Pharmaceutical |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020586 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20010510 |
| Package NDC: | 59148-023-33 |
| Package Description: | 75 mg in 1 KIT (59148-023-33) |
| NDC Code | 59148-023-33 |
| Proprietary Name | Pranactin-Citric |
| Package Description | 75 mg in 1 KIT (59148-023-33) |
| Product NDC | 59148-023 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | UREA C-13 |
| Dosage Form Name | POWDER, FOR SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20010510 |
| Marketing Category Name | NDA |
| Labeler Name | Otsuka America Pharmaceutical |
| Substance Name | UREA C-13 |
| Strength Number | 75 |
| Strength Unit | mg/3000mg |
| Pharmaceutical Classes | Carbon Radioisotopes [Chemical/Ingredient],Helicobacter pylori Diagnostic [EPC],Radioactive Tracers [Chemical/Ingredient],Urea [Chemical/Ingredient] |