Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Lantheus Medical Imaging, Inc.
Lantheus Medical Imaging, Inc.
176786812
Institut National des Radioelements
Lantheus Medical Imaging, Inc.
283049187
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Xenon
Product Details
NDC Product Code
11994-128Application Number
NDA017284Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
November 28, 2022Xenon-133Active
Code: X3P9A5HNYFClass: ACTIBQuantity: 20 mCi in 1 1
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
Xenon
Product Details
NDC Product Code
11994-127Application Number
NDA017284Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
November 28, 2022Xenon-133Active
Code: X3P9A5HNYFClass: ACTIBQuantity: 10 mCi in 1 1
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT