Xenon

Product NDC: 87333-127
11-digit product format: 873330127
Labeler code: 87333
Product ID: 87333-127_a5956751-131b-4a35-9b1f-e3ec97585dc7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Xenon XE-133
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Shine Spect USA, LLC
Application: NDA017284
Marketing category: NDA
Marketing start: 2026-09-10
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Xenon
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
XENON XE-133	10 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
74f95143-d3b4-4e69-b200-e09bf811516b	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xenon	XENON XE-133	Shine Spect USA, LLC	74f95143-d3b4-4e69-b200-e09bf811516b	2026-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017284 application number: NDA017284 ndc (product): 87333-127
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X3P9A5HNYF	XENON XE-133	14932-42-4	XENON XE-133

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87333-127-11	87333012711	1 VIAL in 1 CAN (87333-127-11) / 1 GAS in 1 VIAL	1 vial	2026-09-10	No	No	Current
87333-127-15	87333012715	5 VIAL in 1 CAN (87333-127-15) / 1 GAS in 1 VIAL	5 vial	2026-09-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XENON Xe 133 GAS FOR DIAGNOSTIC USE	Shine Spect USA, LLC \| Institut National des Radioelements	2026-09-10	HUMAN PRESCRIPTION DRUG LABEL	2