Package 50402-100-13
Brand: idkit hp one
Generic: citric acid anhydrous and 13c ureaPackage Facts
Identity
Package NDC
50402-100-13
Digits Only
5040210013
Product NDC
50402-100
Description
25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAG
Marketing
Marketing Status
Brand
idkit hp one
Generic
citric acid anhydrous and 13c urea
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "14276165-5001-4e53-a474-d7cf6931f051", "openfda": {"nui": ["M0003375", "N0000175886", "M0018403", "M0022315"], "unii": ["2968PHW8QP", "W6KX9E6D8X"], "spl_set_id": ["8baab7a7-5d20-46ad-9c4a-762992ef6b51"], "pharm_class_cs": ["Carbon Radioisotopes [CS]", "Radioactive Tracers [CS]", "Urea [CS]"], "pharm_class_epc": ["Helicobacter pylori Diagnostic [EPC]"], "manufacturer_name": ["Meridian Bioscience Israel Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAG", "package_ndc": "50402-100-13", "marketing_start_date": "20130501"}, {"sample": false, "description": "5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOX", "package_ndc": "50402-100-14", "marketing_start_date": "20170101"}], "brand_name": "IDkit HP ONE", "product_id": "50402-100_14276165-5001-4e53-a474-d7cf6931f051", "dosage_form": "SOLUTION", "pharm_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 [CS]"], "product_ndc": "50402-100", "generic_name": "citric acid anhydrous and 13C urea", "labeler_name": "Meridian Bioscience Israel Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IDkit HP ONE", "active_ingredients": [{"name": "CITRIC ACID MONOHYDRATE", "strength": "4 g/1"}, {"name": "UREA C-13", "strength": "75 mg/1"}], "application_number": "NDA021314", "marketing_category": "NDA", "marketing_start_date": "20091228", "listing_expiration_date": "20261231"}