Ulspira
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ULSPIRA™ safely and effectively. See full prescribing information for ULSPIRA. ULSPIRA™ (nitric oxide) gas, for inhalation Initial U.S. Approval: 1999
Approved
Approval ID
026e4541-63fa-aebc-e063-6294a90abaea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Airgas Therapeutics, LLC
DUNS: 118537769
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ulspira
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82605-006
Application NumberANDA203144
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ulspira
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (2)
NITRIC OXIDEActive
Quantity: 0.8 mL in 100 L
Code: 31C4KY9ESH
Classification: ACTIB
NITROGENInactive
Quantity: 999.2 mL in 100 L
Code: N762921K75
Classification: IACT