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Noxivent 102

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

27586e4f-66f1-4583-981c-e0bccb8b02e0

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 102

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59579-102
Application NumberANDA207141
Product Classification
M
Marketing Category
C73584
G
Generic Name
Noxivent 102
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 19, 2023
FDA Product Classification

INGREDIENTS (2)

NITROGENInactive
Code: N762921K75
Classification: IACT
NITRIC OXIDEActive
Quantity: 800 mg in 1 L
Code: 31C4KY9ESH
Classification: ACTIB

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Noxivent 102 - FDA Drug Approval Details