INOMAX

Product NDC: 64693-003
11-digit product format: 646930003
Labeler code: 64693
Product ID: 64693-003_6fa12acd-30da-4725-953d-68a30b52b66a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitric oxide
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: INO Therapeutics LLC
Application: NDA020845
Marketing category: NDA
Marketing start: 2023-01-17
Substance: NITRIC OXIDE
Active strength: 6 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020845-002	INOMAX	NITRIC OXIDE	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23
N020845-003	INOMAX	NITRIC OXIDE	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23
N020845-004	INOMAX	NITRIC OXIDE	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020845-003	AA

Orange Book patents#

Current patent rows page 1 of 1 · 53 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N020845-002	8282966	2029-06-30	U-1286		2012-10-10
N020845-002	8293284	2029-06-30	U-1286
N020845-002	8431163	2029-06-30	U-1286		2013-05-01
N020845-002	8795741	2029-06-30	U-1286		2014-08-07
N020845-002	8846112	2029-06-30	U-1286		2014-10-02
N020845-002	8282966*PED	2029-12-30		Pediatric extension
N020845-002	8293284*PED	2029-12-30		Pediatric extension
N020845-002	8431163*PED	2029-12-30		Pediatric extension
N020845-002	8795741*PED	2029-12-30		Pediatric extension
N020845-002	8846112*PED	2029-12-30		Pediatric extension
N020845-002	8291904	2031-01-06	U-1226	Drug product
N020845-002	8573209	2031-01-06		Drug product	2013-12-04
N020845-002	8573210	2031-01-06	U-1453	Drug product	2013-12-04
N020845-002	8776794	2031-01-06	U-1226	Drug product	2014-07-23
N020845-002	8776795	2031-01-06	U-1226	Drug product	2014-07-23
N020845-002	8291904*PED	2031-07-06		Pediatric extension
N020845-002	8573209*PED	2031-07-06		Pediatric extension
N020845-002	8573210*PED	2031-07-06		Pediatric extension
N020845-002	8776794*PED	2031-07-06		Pediatric extension
N020845-002	8776795*PED	2031-07-06		Pediatric extension
N020845-003	11931377	2029-06-30	U-3903	Drug substance, Drug product	2024-05-06
N020845-003	8282966	2029-06-30	U-1286
N020845-003	8293284	2029-06-30	U-1286
N020845-003	8431163	2029-06-30	U-1286
N020845-003	8795741	2029-06-30	U-1286		2014-08-07
N020845-003	8846112	2029-06-30	U-1286		2014-10-02
N020845-003	11931377*PED	2029-12-30		Pediatric extension
N020845-003	8282966*PED	2029-12-30		Pediatric extension
N020845-003	8293284*PED	2029-12-30		Pediatric extension
N020845-003	8431163*PED	2029-12-30		Pediatric extension
N020845-003	8795741*PED	2029-12-30		Pediatric extension
N020845-003	8846112*PED	2029-12-30		Pediatric extension
N020845-003	8291904	2031-01-06	U-1226	Drug product
N020845-003	8573209	2031-01-06		Drug product	2013-12-04
N020845-003	8573210	2031-01-06	U-1453	Drug product	2013-12-04
N020845-003	8776794	2031-01-06	U-1226	Drug product	2014-07-23
N020845-003	8776795	2031-01-06	U-1226	Drug product	2014-07-23
N020845-003	9265911	2031-01-06	U-1824	Drug product	2016-03-18
N020845-003	9295802	2031-01-06	U-1226	Drug product	2016-04-06
N020845-003	9408993	2031-01-06	U-1824	Drug product	2016-08-17
N020845-003	8291904*PED	2031-07-06		Pediatric extension
N020845-003	8573209*PED	2031-07-06		Pediatric extension
N020845-003	8573210*PED	2031-07-06		Pediatric extension
N020845-003	8776794*PED	2031-07-06		Pediatric extension
N020845-003	8776795*PED	2031-07-06		Pediatric extension
N020845-003	9265911*PED	2031-07-06		Pediatric extension
N020845-003	9295802*PED	2031-07-06		Pediatric extension
N020845-003	9408993*PED	2031-07-06		Pediatric extension
N020845-003	9279794	2035-02-19	U-1823	Drug product	2016-03-18
N020845-003	9279794*PED	2035-08-19		Pediatric extension
N020845-003	9770570	2036-05-03	U-2148		2017-10-25
N020845-003	9770570*PED	2036-11-03		Pediatric extension
N020845-004	11931377	2029-06-30	U-3903	Drug substance, Drug product	2024-05-06

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 · 96 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	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020845-003	INOMAX	800PPM	GAS / INHALATION	AA	RLD, RS	1999-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020845-004	INOMAX	4880PPM	GAS / INHALATION		RLD, RS	2023-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020845-002	INOMAX	100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GAS / INHALATION		RLD	1999-12-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020845-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020845-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020845-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020845-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020845-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020845-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020845-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020845-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020845-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020845-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020845-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020845-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020845-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020845-003	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020845-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020845-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020845-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020845-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020845-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020845-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020845-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020845-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020845-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020845-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020845-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020845-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020845-003	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020845-003	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020845-003	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020845-003	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020845-003	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020845-003	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020845-003	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020845-003	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020845-003	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020845-003	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020845-003	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020845-003	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020845-003	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020845-003	AA	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 53 · 2,092 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	N020845-002	8282966	2029-06-30	U-1286		2012-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8293284	2029-06-30	U-1286			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8431163	2029-06-30	U-1286		2013-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8795741	2029-06-30	U-1286		2014-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8846112	2029-06-30	U-1286		2014-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8282966*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8293284*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8431163*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8795741*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8846112*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8291904	2031-01-06	U-1226	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8573209	2031-01-06		Drug product	2013-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8573210	2031-01-06	U-1453	Drug product	2013-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8776794	2031-01-06	U-1226	Drug product	2014-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8776795	2031-01-06	U-1226	Drug product	2014-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8291904*PED	2031-07-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8573209*PED	2031-07-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8573210*PED	2031-07-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8776794*PED	2031-07-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-002	8776795*PED	2031-07-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	11931377	2029-06-30	U-3903	Drug substance, Drug product	2024-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8282966	2029-06-30	U-1286			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8293284	2029-06-30	U-1286			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8431163	2029-06-30	U-1286			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8795741	2029-06-30	U-1286		2014-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8846112	2029-06-30	U-1286		2014-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	11931377*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8282966*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8293284*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8431163*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8795741*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8846112*PED	2029-12-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8291904	2031-01-06	U-1226	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8573209	2031-01-06		Drug product	2013-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8573210	2031-01-06	U-1453	Drug product	2013-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8776794	2031-01-06	U-1226	Drug product	2014-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	8776795	2031-01-06	U-1226	Drug product	2014-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	9265911	2031-01-06	U-1824	Drug product	2016-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	9295802	2031-01-06	U-1226	Drug product	2016-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020845-003	9408993	2031-01-06	U-1824	Drug product	2016-08-17	`011fe1cb6892…`

Additional Listing Data#

Finished product: Yes
Brand name base: INOMAX
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITRIC OXIDE	6 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
827693	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
762b51be-1893-4cd1-9511-e645fc420d3a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
46e64ad7-7dca-4816-a2a4-8cdff2136105	Product name	2	20240828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64693-003-01	INOMAX	78 L in 1 CYLINDER	GAS	78		19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
nitric oxide	ACTIVE INGREDIENT	31C4KY9ESH	INOMAX (NITRIC OXIDE) GAS [INO THERAPEUTICS]	12
nitric oxide	ACTIVE MOIETY	31C4KY9ESH	INOMAX (NITRIC OXIDE) GAS [INO THERAPEUTICS]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64693-003	INOMAX (NITRIC OXIDE) GAS [INO THERAPEUTICS LLC]	18	Current NDC, 1 package rows	20241211_762b51be-1893-4cd1-9511-e645fc420d3a.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INOMAX	NITRIC OXIDE	INO Therapeutics LLC	762b51be-1893-4cd1-9511-e645fc420d3a	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020845 application number: NDA020845 ndc (product): 64693-003

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
827693	INOmax 800 PPM Gas for Inhalation	PSN	762b51be-1893-4cd1-9511-e645fc420d3a	19
582608	nitric oxide 800 PPM Gas for Inhalation	PSN	762b51be-1893-4cd1-9511-e645fc420d3a	19
827693	nitric oxide 0.08 % / nitrogen 99.92 % Gas for Inhalation [INOmax]	SBD	762b51be-1893-4cd1-9511-e645fc420d3a	19
582608	nitric oxide 0.08 % / nitrogen 99.92 % Gas for Inhalation	SCD	762b51be-1893-4cd1-9511-e645fc420d3a	19
827693	INOmax 0.08 % / 99.92 % Gas for Inhalation	SY	762b51be-1893-4cd1-9511-e645fc420d3a	19
827693	INOmax 800 PPM Gas for Inhalation	SY	762b51be-1893-4cd1-9511-e645fc420d3a	19
582608	nitric oxide 800 PPM Gas for Inhalation	SY	762b51be-1893-4cd1-9511-e645fc420d3a	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64693-003-01	64693000301	78 L in 1 CYLINDER (64693-003-01)	78 l	2023-01-17	No	No	Current