Noxivent 101
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NOXIVENT™ safely and effectively. See full prescribing information for NOXIVENT™. NOXIVENT™ (nitric oxide) gas, for inhalation Initial U.S. Approval: 1999
Approved
Approval ID
c9b59507-e3d4-47e6-87e1-5edf678bcf00
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2023
Manufacturers
FDA
Linde Gas & Equipment Inc
DUNS: 042845636
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Noxivent 101
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59579-101
Application NumberANDA207141
Product Classification
M
Marketing Category
C73584
G
Generic Name
Noxivent 101
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (2)
NITROGENInactive
Code: N762921K75
Classification: IACT
NITRIC OXIDEActive
Quantity: 100 mg in 1 L
Code: 31C4KY9ESH
Classification: ACTIB