Xenon

Product NDC
11994-127
11-digit product format
119940127
Labeler code
11994
Product ID
11994-127_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
10 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-13310 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
11994-127-11Xenon1 in 1 CANGAS117
11994-127-11Xenon1 in 1 VIALGAS117
11994-127-15Xenon1 in 1 VIALGAS117
11994-127-15Xenon5 in 1 CANGAS517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11994-127-11EA - Each11994-127add5dd4f-6c36-4fb8-a951-78187eca9d3b12015-10-02
11994-127-15EA - Each11994-1270a1156f1-c512-4d73-bd09-fbacfd87947c12017-12-14

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
11994-127XENON (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
11994-127-11119940127111 VIAL in 1 CAN (11994-127-11) / 1 GAS in 1 VIAL1 vial1974-10-100000-00-00NoNoCurrent
11994-127-15119940127155 VIAL in 1 CAN (11994-127-15) / 1 GAS in 1 VIAL5 vial1974-10-100000-00-00NoNoCurrent