Noxivent 101

Product NDC
59579-101
11-digit product format
595790101
Labeler code
59579
Product ID
59579-101_b64f3f65-03ba-48a2-a002-d30c04165bae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Noxivent 101
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Linde Gas & Equipment Inc
Application
ANDA207141
Marketing category
ANDA
Marketing start
2018-10-04
Marketing end
0000-00-00
Substance
NITRIC OXIDE
Active strength
100 mg/L
Pharmacologic classes
Vasodilation [PE],Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59579-101DDiscontinued by firm2026-07-31
excluded packagepackage59579-10159579-101-01DDiscontinued by firm2026-07-31
excluded packagepackage59579-10159579-101-02DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207141-001NOXIVENTNITRIC OXIDE100PPMGAS / INHALATION2018-10-02
A207141-002NOXIVENTNITRIC OXIDE800PPMGAS / INHALATIONAA2018-10-02

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A207141-002AA

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NoxiventNITRIC OXIDEVERO BIOTECH, INC.4ff98b29-bcd3-82eb-e063-6394a90abf8c2026-04-20Warnings, Adverse reactionsExact identifier
Noxivent 102NOXIVENT 102Linde Gas & Equipment Inc27586e4f-66f1-4583-981c-e0bccb8b02e02025-11-13Warnings, Adverse reactionsExact identifier

Warnings cross-check#

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

warnings and cautions

WARNINGS AND PRECAUTIONS Rebound: Abrupt discontinuation of Noxivent™ may lead to worsening oxygenation and increasing pulmonary artery pressure ( 5.1 ). Methemoglobinemia: Methemoglobin increases with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours ( 5.2 ). Elevated NO 2 Levels: Monitor NO 2 levels ( 5.3 ). Heart Failure: In patients with pre-existing left ventricular dysfunction, Noxivent™ may increase pulmonary capillary wedge pressure leading to pulmonary edema ( 5.4 ).

warnings and cautions

5. WARNINGS AND PRECAUTIONS

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The most common adverse reaction is hypotension. ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact contact Vero Biotech at 1-833-669-8368 and http://www.vero-biotech.com/ or FDA at 1-800-FDA-1088 or or www.fda.gov/medwatch .

adverse reactions

6. ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the label; Hypoxemia [see Warnings and Precautions (5.2 )] Worsening Heart Failure [see Warnings and Precautions (5.4 )]

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59579-101NOXIVENT 101 GAS [LINDE GAS & EQUIPMENT INC]8Legacy NDC20250126_c9b59507-e3d4-47e6-87e1-5edf678bcf00.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59579-101-01595790101012082 L in 1 CYLINDER (59579-101-01) 2082 l2018-10-040000-00-00NoNoCurrent
59579-101-0259579010102323 L in 1 CYLINDER (59579-101-02) 323 l2018-10-040000-00-00NoNoCurrent