Noxivent 101

Product NDC: 59579-101
11-digit product format: 595790101
Labeler code: 59579
Product ID: 59579-101_b64f3f65-03ba-48a2-a002-d30c04165bae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Noxivent 101
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Linde Gas & Equipment Inc
Application: ANDA207141
Marketing category: ANDA
Marketing start: 2018-10-04
Marketing end: 0000-00-00
Substance: NITRIC OXIDE
Active strength: 100 mg/L
Pharmacologic classes: Vasodilation [PE],Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59579-101		D	Discontinued by firm	2026-08-17
excluded package	package	59579-101	59579-101-01	D	Discontinued by firm	2026-08-17
excluded package	package	59579-101	59579-101-02	D	Discontinued by firm	2026-08-17

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59579-101-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59579-101-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59579-101-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59579-101-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59579-101-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59579-101-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 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	A207141-001	NOXIVENT	100PPM	GAS / INHALATION			2018-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207141-002	NOXIVENT	800PPM	GAS / INHALATION	AA		2018-10-02	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207141-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207141-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207141-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207141-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207141-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207141-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207141-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207141-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207141-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207141-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207141-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207141-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207141-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207141-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207141-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207141-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207141-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207141-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207141-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207141-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207141-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207141-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207141-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207141-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207141-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207141-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207141-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207141-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207141-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207141-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207141-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207141-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207141-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207141-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207141-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207141-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207141-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207141-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207141-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207141-002	AA	1	`e64feba35796…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59579-101	NOXIVENT 101 GAS [LINDE GAS & EQUIPMENT INC]	8	Legacy NDC	20250126_c9b59507-e3d4-47e6-87e1-5edf678bcf00.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Noxivent	NITRIC OXIDE	VERO BIOTECH, INC.	4ff98b29-bcd3-82eb-e063-6394a90abf8c	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207141 application number: ANDA207141
Noxivent 102	NOXIVENT 102	Linde Gas & Equipment Inc	27586e4f-66f1-4583-981c-e0bccb8b02e0	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207141 application number: ANDA207141

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
31C4KY9ESH	NITRIC OXIDE	10102-43-9	NITRIC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59579-101-01	59579010101	2082 L in 1 CYLINDER (59579-101-01)	2082 l	2018-10-04	0000-00-00	No	No	Current
59579-101-02	59579010102	323 L in 1 CYLINDER (59579-101-02)	323 l	2018-10-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Noxivent 101 - Linde Gas & Equipment Inc	Linde Gas & Equipment Inc	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	8