Ulspira

Product NDC: 82605-006
Requested package NDC: 82605-006-01
11-digit product format: 826050006
Labeler code: 82605
Product ID: 82605-006_3a136eac-7cc3-31ea-e063-6294a90afb91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ulspira
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Airgas Therapeutics, LLC
Application: ANDA203144
Marketing category: ANDA
Marketing start: 2023-08-04
Substance: NITRIC OXIDE
Active strength: .8 mL/100L
Pharmacologic classes: Vasodilation [PE], Vasodilator [EPC]
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 · 5 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`

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
A203144-001	ULSPIRA	NITRIC OXIDE	800PPM	GAS / INHALATION	AA		2023-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203144-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203144-001	ULSPIRA	800PPM	GAS / INHALATION	AA	2023-07-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203144-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203144-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203144-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203144-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203144-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203144-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203144-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203144-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203144-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203144-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203144-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203144-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203144-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203144-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203144-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203144-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203144-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203144-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203144-001	AA	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203144-001	AA	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITRIC OXIDE	.8 mL/100L

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
582608	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
026e4541-63fa-aebc-e063-6294a90abaea	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
82605-006-01	Ulspira	2138 L in 1 CYLINDER	GAS	2138		32
82605-006-02	Ulspira	362 L in 1 CYLINDER	GAS	362		32

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
Ulspira	NITRIC OXIDE	Airgas Therapeutics, LLC	2c605fc0-82be-09e0-e063-6394a90a63e9	2025-10-30	Warnings	Exact identifier application applno (ANDA): 203144 application number: ANDA203144
Ulspira	ULSPIRA	Airgas Therapeutics, LLC	026e4541-63fa-aebc-e063-6294a90abaea	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203144 application number: ANDA203144 ndc (package): 82605-006-01 ndc (product): 82605-006 ndc11 (package): 82605000601

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
582608	nitric oxide 800 PPM Gas for Inhalation	PSN	026e4541-63fa-aebc-e063-6294a90abaea	32
582608	nitric oxide 0.08 % / nitrogen 99.92 % Gas for Inhalation	SCD	026e4541-63fa-aebc-e063-6294a90abaea	32
582608	nitric oxide 800 PPM Gas for Inhalation	SY	026e4541-63fa-aebc-e063-6294a90abaea	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82605-006-01	82605000601	2138 L in 1 CYLINDER (82605-006-01)	2138 l	2023-08-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ulspira - Airgas Therapeutics, LLC	Airgas Therapeutics, LLC	2025-07-16	HUMAN PRESCRIPTION DRUG LABEL	32