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Heliox

Prescription NDA

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Heliox

Generic name

Heliox

Dosage form

Gas

Route

Respiratory (Inhalation)

Marketing category

NDA · NDA

Labeler

Metro Welding Supply Corporation

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

46% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Oxygen	200 mL/L	312172	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Gas

Route of administration

Respiratory (Inhalation)

Presentations

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

205849

Application type

NDA · New Drug Application

Approval date

July 21, 2013

Sponsor

PRAXAIR INC

Products on application

Submissions recorded

Products approved under application 205849.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
205849-001	OXYGEN, USP	GAS		OXYGEN	Prescription	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 205849.
Type	No.	Action	Status	Date	Review
Original application	1	Medical Gas	Approved	July 21, 2013	Standard

Review documents

0 · Original application · September 30, 2015

Adverse event reports

Source: openFDA FAERS

48,982

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: OXYGEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
10297-080-01	10297-080	A-OX Welding Supply, LLC	637.13 L in 1 CYLINDER (10297-080-01)	June 1, 2018
10297-080-02	10297-080	A-OX Welding Supply, LLC	5810.62 L in 1 CYLINDER (10297-080-02)	June 1, 2018
10297-080-03	10297-080	A-OX Welding Supply, LLC	7744.66 L in 1 CYLINDER (10297-080-03)	June 1, 2018
62273-007-01	62273-007	Metro Welding Supply Corporation	8495.05 L in 1 CYLINDER (62273-007-01)	March 28, 2019
62273-007-02	62273-007	Metro Welding Supply Corporation	5663.37 L in 1 CYLINDER (62273-007-02)	March 28, 2019
62273-007-03	62273-007	Metro Welding Supply Corporation	3539.61 L in 1 CYLINDER (62273-007-03)	March 28, 2019
10297-080	10297-080	A-OX Welding Supply, LLC	—	June 1, 2018
62273-007	62273-007	Metro Welding Supply Corporation	—	March 28, 2019

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 8 sections on this page.