idkit hp one

Generic: citric acid anhydrous and 13c urea

Labeler: meridian bioscience israel ltd
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name idkit hp one
Generic Name citric acid anhydrous and 13c urea
Labeler meridian bioscience israel ltd
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

citric acid monohydrate 4 g/1, urea c-13 75 mg/1

Manufacturer
Meridian Bioscience Israel Ltd

Identifiers & Regulatory

Product NDC 50402-100
Product ID 50402-100_14276165-5001-4e53-a474-d7cf6931f051
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021314
Listing Expiration 2026-12-31
Marketing Start 2009-12-28

Pharmacologic Class

Established (EPC)
helicobacter pylori diagnostic [epc]
Chemical Structure
carbon radioisotopes [cs] radioactive tracers [cs] urea [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50402100
Hyphenated Format 50402-100

Supplemental Identifiers

UNII
2968PHW8QP W6KX9E6D8X
NUI
M0003375 N0000175886 M0018403 M0022315

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name idkit hp one (source: ndc)
Generic Name citric acid anhydrous and 13c urea (source: ndc)
Application Number NDA021314 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 g/1
  • 75 mg/1
source: ndc
Packaging
  • 25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAG
  • 5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOX
source: ndc

Packages (2)

50402-100-13 25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAG 50402-100-14 5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOX

Ingredients (2)

citric acid monohydrate (4 g/1) urea c-13 (75 mg/1)

Linked Drug Pages (1)

IDkit HP ONE ndc-match (0.9)

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"}