Label: ULSPIRA- nitric oxide gas
- NDC Code(s): 82605-008-01, 82605-008-02
- Packager: Airgas Therapeutics, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 30, 2025
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WARNINGS
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.
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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
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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
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INGREDIENTS AND APPEARANCE
ULSPIRA
nitric oxide gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82605-008 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITRIC OXIDE (UNII: 31C4KY9ESH) (NITRIC OXIDE - UNII:31C4KY9ESH) NITRIC OXIDE 0.8 mL in 100 L Inactive Ingredients Ingredient Name Strength NITROGEN (UNII: N762921K75) 999.2 mL in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82605-008-01 2138 L in 1 CYLINDER; Type 0: Not a Combination Product 08/04/2023 2 NDC:82605-008-02 362 L in 1 CYLINDER; Type 0: Not a Combination Product 08/04/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203144 08/04/2023 Labeler - Airgas Therapeutics, LLC (118537769) Establishment Name Address ID/FEI Business Operations Airgas Therapeutics, LLC 118537769 manufacture(82605-008)