Home NDC 72385-002 GENOSYL
Product NDC 72385-002
11-digit product format 723850002
Labeler code 72385
Product ID 72385-002_45245ace-7b4e-290f-e063-6394a90a8c7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nitric oxide
Dosage form GAS
Route RESPIRATORY (INHALATION)
Labeler VERO BIOTECH, INC.
Application NDA202860
Marketing category NDA
Marketing start 2022-12-28
Substance NITRIC OXIDE
Active strength .98 mg/L
Pharmacologic classes Vasodilation [PE], Vasodilator [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202860-001 GENOSYL NITRIC OXIDE 800PPM GAS / INHALATION RLD, RS 2019-12-20
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202860-001 8057742 2026-01-18 U-3037 2021-01-15 N202860-001 7618594 2026-10-17 Drug product 2020-06-10 N202860-001 7947227 2026-10-17 U-3037 2021-01-15 N202860-001 7560076 2027-04-21 Drug product 2020-06-10 N202860-001 9701538 2029-01-28 Drug product 2021-01-15 N202860-001 10926054 2029-08-13 Drug product 2021-03-09 N202860-001 8944049 2029-08-13 Drug product 2021-01-15 N202860-001 9604028 2029-08-13 U-2793 2020-05-05 N202860-001 11511252 2029-09-21 Drug product 2023-01-11 N202860-001 11103669 2030-06-21 Drug product 2021-09-23 N202860-001 8607785 2030-07-14 Drug product 2021-01-15 N202860-001 10737051 2035-10-20 Drug product 2020-08-21 N202860-001 10213572 2036-02-12 Drug product 2020-05-05 N202860-001 11672938 2040-07-22 U-3037 2023-07-14
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 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N202860-001 GENOSYL 800PPM GAS / INHALATION RLD, RS 2019-12-20 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 20 · 788 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 N202860-001 8057742 2026-01-18 U-3037 2021-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 7618594 2026-10-17 Drug product 2020-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 7947227 2026-10-17 U-3037 2021-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 7560076 2027-04-21 Drug product 2020-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 9701538 2029-01-28 Drug product 2021-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 10926054 2029-08-13 Drug product 2021-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 8944049 2029-08-13 Drug product 2021-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 9604028 2029-08-13 U-2793 2020-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 11511252 2029-09-21 Drug product 2023-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 11103669 2030-06-21 Drug product 2021-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 8607785 2030-07-14 Drug product 2021-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 10737051 2035-10-20 Drug product 2020-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 10213572 2036-02-12 Drug product 2020-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202860-001 11672938 2040-07-22 U-3037 2023-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 10124142 2025-08-18 U-3037 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 11291793 2025-08-18 Drug product 2022-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 11383059 2025-08-18 U-3037 2022-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 11554241 2025-08-18 U-3037 2023-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 8226916 2025-08-18 U-3037 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 8609028 2025-08-18 U-3037 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 8821801 2025-08-18 Drug product 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 9522249 2025-08-18 Drug product 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 9956373 2025-08-18 U-3037 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 10814092 2025-10-17 U-3037 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 8057742 2026-01-18 U-3037 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 7618594 2026-10-17 Drug product 2020-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 7947227 2026-10-17 U-3037 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 7560076 2027-04-21 Drug product 2020-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 9701538 2029-01-28 Drug product 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 10926054 2029-08-13 Drug product 2021-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 8944049 2029-08-13 Drug product 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 9604028 2029-08-13 U-2793 2020-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 11511252 2029-09-21 Drug product 2023-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 11103669 2030-06-21 Drug product 2021-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 8607785 2030-07-14 Drug product 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 10737051 2035-10-20 Drug product 2020-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 10213572 2036-02-12 Drug product 2020-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202860-001 11672938 2040-07-22 U-3037 2023-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202860-001 10124142 2025-08-18 U-3037 2021-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202860-001 11291793 2025-08-18 Drug product 2022-05-05 6a471c1ec25d…
Additional Listing Data#
Finished product Yes
Brand name base GENOSYL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITRIC OXIDE .98 mg/L
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 31C4KY9ESH Internal UNII lookup
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 72385-002-01 GENOSYL 216 L in 1 CARTRIDGE GAS 216 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72385-002 GENOSYL (NITRIC OXIDE) GAS [VERO BIOTECH, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20241210_8e6b2a92-7915-4709-9076-3a591bf195eb.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 · 3 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 72385-002-01 72385000201 216 L in 1 CARTRIDGE (72385-002-01) 216 l 2022-12-28 0000-00-00 No No Current