Helium Oxygen mixture

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 078301808

Effective Date

October 5, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Helium(700 mL in 1 L)

Oxygen(300 mL in 1 L)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Airgas Usa, LLC

DUNS Number

947401071

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

11054-032

Application Number

NDA205843

Marketing Category

NDA authorized generic (C73605)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

July 12, 2018

Ingredients

Code: 206GF3GB41Class: ACTIBQuantity: 700 mL in 1 L

Code: S88TT14065Class: ACTIBQuantity: 300 mL in 1 L