Home NDC 11994-128 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N017284-001 XENON XE 133 XENON XE-133 10mCi/VIAL GAS / INHALATION Approved before 1982 N017284-002 XENON XE 133 XENON XE-133 20mCi/VIAL GAS / INHALATION Approved before 1982
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 · 84 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 2026-08-18 06:07:40 2026-07 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N017284-001 XENON XE 133 10mCi/VIAL GAS / INHALATION Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N017284-002 XENON XE 133 20mCi/VIAL GAS / INHALATION Approved before 1982 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Xenon
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength XENON XE-133 20 mCi/1
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 Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11994-128 XENON (XENON XE-133) GAS [LANTHEUS MEDICAL IMAGING, INC.] 17 Current NDC, Legacy NDC, 4 package rows 20221130_35bdc182-2a41-41d2-8fe7-aa0c140d4425.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xenon XENON XE-133 Lantheus Medical Imaging, Inc. 35bdc182-2a41-41d2-8fe7-aa0c140d4425 2022-11-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 017284 application number: NDA017284 ndc (product): 11994-128
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11994-128-21 11994012821 1 VIAL in 1 CAN (11994-128-21) / 1 GAS in 1 VIAL 1 vial 1974-10-10 0000-00-00 No No Current 11994-128-25 11994012825 5 VIAL in 1 CAN (11994-128-25) / 1 GAS in 1 VIAL 5 vial 1974-10-10 0000-00-00 No No Current