Xenon, Xe-133

Product NDC
69945-098
11-digit product format
699450098
Labeler code
69945
Product ID
69945-098_2499af1e-e636-286e-e063-6394a90a7bbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Xenon
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Curium US LLC
Application
NDA018327
Marketing category
NDA
Marketing start
2016-03-30
Substance
XENON XE-133
Active strength
10 mCi/mL
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, Xe-133
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
XENON XE-13310 mCi/mL

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
69945-098-21Xenon, Xe-1331 in 1 CANGAS120
69945-098-21Xenon, Xe-1331 in 1 CONTAINERGAS120
69945-098-23Xenon, Xe-1331 in 1 CANGAS120
69945-098-23Xenon, Xe-1333 in 1 CONTAINERGAS320
69945-098-25Xenon, Xe-1331 in 1 CANGAS120
69945-098-25Xenon, Xe-1335 in 1 CONTAINERGAS520

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69945-098XENON, XE-133 (XENON) GAS [CURIUM US LLC]20Current NDC, Legacy NDC, 6 package rows20241018_5eb971be-8808-4aeb-9898-0d22d5dffe04.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69945-098-21699450098211 CAN in 1 CONTAINER (69945-098-21) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE1 can2016-03-300000-00-00NoNoCurrent
69945-098-23699450098233 CAN in 1 CONTAINER (69945-098-23) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE3 can2016-03-300000-00-00NoNoCurrent
69945-098-25699450098255 CAN in 1 CONTAINER (69945-098-25) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE5 can2016-03-300000-00-00NoNoCurrent