xenon, xe-133

Generic: xenon

Labeler: curium us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xenon, xe-133
Generic Name xenon
Labeler curium us llc
Dosage Form GAS
Routes
RESPIRATORY (INHALATION)
Active Ingredients

xenon xe-133 5 mCi/mL

Manufacturer
Curium US LLC

Identifiers & Regulatory

Product NDC 69945-097
Product ID 69945-097_2499af1e-e636-286e-e063-6394a90a7bbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018327
Listing Expiration 2026-12-31
Marketing Start 2016-03-30

Pharmacologic Class

Established (EPC)
inhalation diagnostic agent [epc]
Mechanism of Action
radiopharmaceutical activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69945097
Hyphenated Format 69945-097

Supplemental Identifiers

UNII
X3P9A5HNYF
NUI
N0000175866 N0000000205

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 xenon, xe-133 (source: ndc)
Generic Name xenon (source: ndc)
Application Number NDA018327 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 5 mCi/mL
source: ndc
Packaging
  • 1 CAN in 1 CONTAINER (69945-097-11) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE
  • 3 CAN in 1 CONTAINER (69945-097-13) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE
  • 5 CAN in 1 CONTAINER (69945-097-15) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE
source: ndc

Packages (3)

69945-097-11 1 CAN in 1 CONTAINER (69945-097-11) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE 69945-097-13 3 CAN in 1 CONTAINER (69945-097-13) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE 69945-097-15 5 CAN in 1 CONTAINER (69945-097-15) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE

Ingredients (1)

xenon xe-133 (5 mCi/mL)

Linked Drug Pages (1)

Xenon, Xe-133 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "2499af1e-e636-286e-e063-6394a90a7bbf", "openfda": {"nui": ["N0000175866", "N0000000205"], "unii": ["X3P9A5HNYF"], "spl_set_id": ["5eb971be-8808-4aeb-9898-0d22d5dffe04"], "pharm_class_epc": ["Inhalation Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Curium US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CAN in 1 CONTAINER (69945-097-11)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE", "package_ndc": "69945-097-11", "marketing_start_date": "20160330"}, {"sample": false, "description": "3 CAN in 1 CONTAINER (69945-097-13)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE", "package_ndc": "69945-097-13", "marketing_start_date": "20160330"}, {"sample": false, "description": "5 CAN in 1 CONTAINER (69945-097-15)  / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE", "package_ndc": "69945-097-15", "marketing_start_date": "20160330"}], "brand_name": "Xenon, Xe-133", "product_id": "69945-097_2499af1e-e636-286e-e063-6394a90a7bbf", "dosage_form": "GAS", "pharm_class": ["Inhalation Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "69945-097", "generic_name": "Xenon", "labeler_name": "Curium US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xenon, Xe-133", "active_ingredients": [{"name": "XENON XE-133", "strength": "5 mCi/mL"}], "application_number": "NDA018327", "marketing_category": "NDA", "marketing_start_date": "20160330", "listing_expiration_date": "20261231"}