Ulspira

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Ulspira
Generic name: NITRIC OXIDE
Manufacturer: Airgas Therapeutics, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 2c605fc0-82be-09e0-e063-6394a90a63e9
SPL ID: 42659119-4ca6-acf0-e063-6294a90a52ee
Version: 15
Effective date: 2025-10-30
Source export date: 2026-11-06
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:47:32

Harmonized routes table
Harmonized routes
RESPIRATORY (INHALATION)

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	203144	derived:openfda.application_number
application number		ANDA203144	openfda.application_number
brand name		Ulspira	openfda.brand_name
generic name		NITRIC OXIDE	openfda.generic_name
manufacturer name		Airgas Therapeutics, LLC	openfda.manufacturer_name
ndc	package	82605-008-02	openfda.package_ndc
ndc	package	82605-008-01	openfda.package_ndc
ndc	product	82605-008	openfda.product_ndc
ndc11	package	82605000802	derived:openfda.package_ndc
ndc11	package	82605000801	derived:openfda.package_ndc
rxcui		582608	openfda.rxcui
rxcui		2702871	openfda.rxcui
spl id		42659119-4ca6-acf0-e063-6294a90a52ee	id
spl set id		2c605fc0-82be-09e0-e063-6394a90a63e9	set_id
unii		31C4KY9ESH	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

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.

Reported adverse events (FAERS/openFDA)#

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