Helium, Oxygen
Helium Oxygen Mix 80/20 - 041
Approved
Approval ID
58ba729f-cca1-4e08-a131-dbe91258d99d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
AIRGAS USA, LLC
DUNS: 078301808
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Helium, Oxygen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11054-041
Application NumberNDA205843
Product Classification
M
Marketing Category
C73605
G
Generic Name
Helium, Oxygen
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 21, 2018
FDA Product Classification
INGREDIENTS (2)
HELIUMActive
Quantity: 800 mL in 1 L
Code: 206GF3GB41
Classification: ACTIB
OXYGENActive
Quantity: 200 mL in 1 L
Code: S88TT14065
Classification: ACTIB