Xenon

Product NDC
11994-128
11-digit product format
119940128
Labeler code
11994
Product ID
11994-128_ed8bea93-8d9f-4442-98ad-af0fd909cc6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Xenon XE-133
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Lantheus Medical Imaging, Inc.
Application
NDA017284
Marketing category
NDA
Marketing start
1974-10-10
Substance
XENON XE-133
Active strength
20 mCi/1
Pharmacologic classes
Inhalation Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xenon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
XENON XE-13320 mCi/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P9A5HNYF

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d781ef35-2f26-5079-15a9-686150ca04f9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11994-128-21Xenon1 in 1 CANGAS117
11994-128-21Xenon1 in 1 VIALGAS117
11994-128-25Xenon5 in 1 CANGAS517
11994-128-25Xenon1 in 1 VIALGAS117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11994-128-21EA - Each11994-1281846a8b7-2454-4cbf-b3e6-a8371a9eb48c12015-10-02
11994-128-25EA - Each11994-128d63f6cd6-91aa-48e0-9afb-01111afaaf4c12019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
XENON XE-133ACTIVE INGREDIENTX3P9A5HNYFXENON (XENON XE-133) GAS [LANTHEUS MEDICAL IMAGING, INC.]11
XENON XE-133ACTIVE MOIETYX3P9A5HNYFXENON (XENON XE-133) GAS [LANTHEUS MEDICAL IMAGING, INC.]11
CARBON DIOXIDEINACTIVE INGREDIENT142M471B3JXENON (XENON XE-133) GAS [LANTHEUS MEDICAL IMAGING, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11994-128XENON (XENON XE-133) GAS [LANTHEUS MEDICAL IMAGING, INC.]17Current NDC, Legacy NDC, 4 package rows20221130_35bdc182-2a41-41d2-8fe7-aa0c140d4425.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11994-128-21119940128211 VIAL in 1 CAN (11994-128-21) / 1 GAS in 1 VIAL1 vial1974-10-100000-00-00NoNoCurrent
11994-128-25119940128255 VIAL in 1 CAN (11994-128-25) / 1 GAS in 1 VIAL5 vial1974-10-100000-00-00NoNoCurrent