Ulspira

Manufacturer
Airgas Therapeutics, LLC
Effective date
2025-10-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-05-31 22:04:13

Label at a glance#

ProductUlspira
Active ingredientNITRIC OXIDE
Label structure3 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and if familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ulspira TM

(nitric oxide for inhalation)

800 PPM

Rx Only

CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS.

WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and if familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken.

FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help.

RETURN WITH 25 PSIG.

TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY

AUTHORIZED BY AIRGAS THERAPEUTICS, LLC

Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs).

DO NOT REMOVE THIS PRODUCT LABELS

Store at 25 C (77 F) with excursions permitted between 15 - 30 C (59 – 86 F).

Volume 362 Liters

Airgas Therapeutics

An Air Liquide company

Manufactured by:

AIRGAS THERAPEUTICS, LLC

6141

Easton Road

Plumsteadville, PA 18949-0310

For Product Inquiry 1-833-ULSPIRA (857-7472)

UN 1956

COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2

Net Weight: 0.4 kg

LOT:

EXP:

NDC 82605-005-02

Label No. ULSMD15 Rev. 00

800PPM MD15 nitric oxide onenitric oxide one

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ulspira TM

(nitric oxide for inhalation)

800 PPM

Rx Only

CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS.

WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken.

FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help.

RETURN WITH 25 PSIG.

TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY

AUTHORIZED BY AIRGAS THERAPEUTICS, LLC

Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGmps).

DO NOT REMOVE THIS PRODUCT LABEL

Store at 25 C (77 F) with excursions permitted between 15 – 30 C (59 – 86 F).

Volume 2138 Liters

Airgas Therapeutics

An Air Liquide company

Manufactured by:

AIRGAS THERAPEUTICS, LLC

6141 Easton Road

Plumsteadville, PA 18949-0310

For Product Inquiry 1-833-ULSPIRA (857-7472)

UN1956

COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2

Net Weight: 2.5 kg

LOT:

EXP:

NDC 82605-005-01 nitric oxide twonitric oxide two

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582608nitric oxide 800 PPM Gas for InhalationPSN15
2702871Ulspira 800 PPM Gas for InhalationPSN15
2702871nitric oxide 0.08 % / nitrogen 99.92 % Gas for Inhalation [Ulspira]SBD15
582608nitric oxide 0.08 % / nitrogen 99.92 % Gas for InhalationSCD15
582608nitric oxide 800 PPM Gas for InhalationSY15
2702871Ulspira 800 PPM Gas for InhalationSY15

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NITRIC OXIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
46e64ad7-7dca-4816-a2a4-8cdff2136105Product name220240828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82605-008-01Ulspira2138 L in 1 CYLINDERGAS213815
82605-008-02Ulspira362 L in 1 CYLINDERGAS36215

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82605-00882605-008-01, 82605-008-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
NITROGENN762921K75IACT
NITRIC OXIDE31C4KY9ESHACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203144-001ULSPIRANITRIC OXIDE800PPMGAS / INHALATIONAA2023-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203144-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-2784e616aacf4f…
2026-08-18 06:07:402026-07A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-278072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-279b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203144-001ULSPIRA800PPMGAS / INHALATIONAA2023-07-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203144-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A203144-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203144-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203144-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203144-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203144-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203144-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203144-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203144-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203144-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203144-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203144-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203144-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203144-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203144-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203144-001AA18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203144-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203144-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203144-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203144-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203144-001AA19b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203144-001AA1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UlspiraNITRIC OXIDEAirgas Therapeutics, LLC2c605fc0-82be-09e0-e063-6394a90a63e92025-10-30WarningsExact identifier
ndc (package): 82605-008-02
ndc (package): 82605-008-01
ndc (product): 82605-008
ndc11 (package): 82605000802
ndc11 (package): 82605000801
spl id: 42659119-4ca6-acf0-e063-6294a90a52ee
spl set id: 2c605fc0-82be-09e0-e063-6394a90a63e9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.