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FDA Drug information

Ulspira

Read time: 1 mins
Marketing start date: 23 Nov 2024
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Summary of product characteristics


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.

Effective Time

20231006

Version

4

Spl Product Data Elements

Ulspira Ulspira NITROGEN NITRIC OXIDE NITRIC OXIDE

Application Number

ANDA203144

Brand Name

Ulspira

Generic Name

Ulspira

Product Ndc

82605-006

Product Type

HUMAN PRESCRIPTION DRUG

Route

RESPIRATORY (INHALATION)

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 one

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The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

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