Home NDC 69945-097-11 Xenon, Xe-133
Product NDC 69945-097
Requested package NDC 69945-097-11
11-digit product format 699450097
Labeler code 69945
Product ID 69945-097_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 5 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018327-001 XENON XE 133 XENON XE-133 10mCi/VIAL GAS / INHALATION 1982-03-09 N018327-002 XENON XE 133 XENON XE-133 20mCi/VIAL GAS / INHALATION 1982-03-09
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018327-001 XENON XE 133 10mCi/VIAL GAS / INHALATION 1982-03-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018327-002 XENON XE 133 20mCi/VIAL GAS / INHALATION 1982-03-09 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Xenon, Xe-133
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength XENON XE-133 5 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X3P9A5HNYF Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69945-097 XENON, XE-133 (XENON) GAS [CURIUM US LLC] 20 Current NDC, Legacy NDC, 6 package rows 20241018_5eb971be-8808-4aeb-9898-0d22d5dffe04.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69945-097-11 69945009711 1 CAN in 1 CONTAINER (69945-097-11) / 1 BOTTLE in 1 CAN / 2 mL in 1 BOTTLE 1 can 2016-03-30 0000-00-00 No No Current