Home NDC 80534-6350-1 XENOVIEW
Product NDC 80534-6350
Requested package NDC 80534-6350-1
11-digit product format 805346350
Labeler code 80534
Product ID 80534-6350_2d171c31-4d16-4bc1-9b90-b69631feadd5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name xenon Xe 129 hyperpolarized
Dosage form GAS
Route RESPIRATORY (INHALATION)
Labeler Polarean, Inc.
Application NDA214375
Marketing category NDA
Marketing start 2022-12-23
Substance HELIUM; NITROGEN; XENON XE-129
Active strength 5651.5; 635; 63.5 L/1; L/1; L/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 80534-6350 80534-6350-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214375-001 XENOVIEW XENON XE-129 HYPERPOLARIZED N/A GAS / INHALATION RLD, RS 2022-12-23
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214375-001 10583205 2035-02-20 Drug product 2023-01-20 N214375-001 11052161 2035-12-29 Drug product 2023-01-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214375-001 NCE 2027-12-23
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.
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 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 46 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 a67488948f0b…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base XENOVIEW
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength XENON XE-129 5651.5 L/1 NITROGEN 635 L/1 HELIUM 63.5 L/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80534-6350-1 XENOVIEW 1 in 1 CYLINDER GAS 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80534-6350 XENOVIEW (XENON XE 129 HYPERPOLARIZED) GAS [POLAREAN, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20250112_70e33fe3-c722-439b-b3db-c2a22f229c8a.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 80534-6350-1 80534635001 1 GAS in 1 CYLINDER (80534-6350-1) 1 gas 2022-12-23 0000-00-00 No No Current