Home NDC 72385-102 Noxivent
Product NDC 72385-102
11-digit product format 723850102
Labeler code 72385
Product ID 72385-102_4ff98b9d-ce05-2fb7-e063-6294a90a2c96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nitric oxide
Dosage form GAS
Route RESPIRATORY (INHALATION)
Labeler VERO BIOTECH, INC.
Application ANDA207141
Marketing category ANDA
Marketing start 2018-10-04
Substance NITRIC OXIDE
Active strength 800 mg/L
Pharmacologic classes Vasodilation [PE], Vasodilator [EPC]
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 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 A207141-001 NOXIVENT NITRIC OXIDE 100PPM GAS / INHALATION 2018-10-02 A207141-002 NOXIVENT NITRIC OXIDE 800PPM GAS / INHALATION AA 2018-10-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207141-002 AA
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 A207141-001 NOXIVENT 100PPM GAS / INHALATION 2018-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207141-001 NOXIVENT 100PPM GAS / INHALATION 2018-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207141-001 NOXIVENT 100PPM GAS / INHALATION 2018-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207141-001 NOXIVENT 100PPM GAS / INHALATION RS 2018-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207141-001 NOXIVENT 100PPM GAS / INHALATION RS 2018-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207141-001 NOXIVENT 100PPM GAS / INHALATION RS 2018-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207141-001 NOXIVENT 100PPM GAS / INHALATION RS 2018-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207141-001 NOXIVENT 100PPM GAS / INHALATION RS 2018-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207141-001 NOXIVENT 100PPM GAS / INHALATION RS 2018-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207141-001 NOXIVENT 100PPM GAS / INHALATION RS 2018-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207141-001 NOXIVENT 100PPM GAS / INHALATION RS 2018-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207141-001 NOXIVENT 100PPM GAS / INHALATION RS 2018-10-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207141-001 NOXIVENT 100PPM GAS / INHALATION RS 2018-10-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207141-001 NOXIVENT 100PPM GAS / INHALATION 2018-10-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207141-001 NOXIVENT 100PPM GAS / INHALATION 2018-10-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207141-001 NOXIVENT 100PPM GAS / INHALATION 2018-10-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207141-001 NOXIVENT 100PPM GAS / INHALATION 2018-10-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207141-001 NOXIVENT 100PPM GAS / INHALATION 2018-10-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207141-001 NOXIVENT 100PPM GAS / INHALATION 2018-10-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207141-001 NOXIVENT 100PPM GAS / INHALATION 2018-10-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207141-002 NOXIVENT 800PPM GAS / INHALATION AA 2018-10-02 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Noxivent
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITRIC OXIDE 800 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 582608 Internal RxNorm lookup 2743256 Internal RxNorm 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 72385-102-01 Noxivent 2082 L in 1 CYLINDER GAS 2082 1 72385-102-02 Noxivent 323 L in 1 CYLINDER GAS 323 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72385-102-01 72385010201 2082 L in 1 CYLINDER (72385-102-01) 2082 l 2018-10-04 No No Current 72385-102-02 72385010202 323 L in 1 CYLINDER (72385-102-02) 323 l 2018-10-04 No No Current