Drugplain

Nitrogen 995 mL/L

Nitrogen · GAS · IWS Gas and Supply of Texas, LTD

2 Recalls on Record
Plain English

Nitrogen gas is a prescription inhalation medication supplied at a concentration of 995 mL/L and is used in medical settings for various therapeutic purposes. Your healthcare provider will determine the appropriate use and administration of this gas-based treatment.

Key Facts

Brand Name
Nitrogen
Generic Name
Nitrogen
NDC Code (Product)
53425-002
Manufacturer
IWS Gas and Supply of Texas, LTD
Strength
995 mL/L
Dosage Form
GAS
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
NDA205713
Marketing Start
11/01/2011

Recall History

2 Recalls on Record
Class III03/18/2022

Advanced Accelerator Applications USA, Inc.

Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.

TerminatedVoluntary: Firm initiated
Class II11/26/2024

Curium US, LLC

Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

glossodynia1,632 reports
pemphigus1,613 reports
hand deformity1,604 reports
joint swelling1,590 reports
infusion related reaction1,588 reports
helicobacter infection1,582 reports
impaired healing1,581 reports
irritable bowel syndrome1,574 reports
systemic lupus erythematosus1,569 reports
pericarditis1,561 reports

Full Prescribing Information

Full prescribing information not available for this product.

Frequently Asked Questions

What is Nitrogen used for?

Nitrogen gas is a prescription inhalation medication supplied at a concentration of 995 mL/L and is used in medical settings for various therapeutic purposes. Your healthcare provider will determine the appropriate use and administration of this gas-based treatment.

Is Nitrogen a controlled substance?

Nitrogen is not classified as a controlled substance by the DEA.

What is the generic name for Nitrogen?

The generic name for Nitrogen is Nitrogen. There are 3 other brand versions of Nitrogen.

What is the NDC code for Nitrogen 995 mL/L?

The NDC (National Drug Code) for Nitrogen 995 mL/L is 53425-002, listed by IWS Gas and Supply of Texas, LTD.