Helium/Oxygen Mixture 80/20
Helium/Oxygen Mixture 80/20
Approved
Approval ID
60df34a1-e3fa-6959-e053-2a91aa0a4760
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2023
Manufacturers
FDA
General Air Service & Supply Co.
DUNS: 051227338
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Helium/Oxygen Mixture 80/20
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21220-155
Application NumberNDA205849
Product Classification
M
Marketing Category
C73594
G
Generic Name
Helium/Oxygen Mixture 80/20
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 18, 2023
FDA Product Classification
INGREDIENTS (2)
HELIUMInactive
Quantity: 800 mL in 1 L
Code: 206GF3GB41
Classification: IACT
OXYGENActive
Quantity: 200 mL in 1 L
Code: S88TT14065
Classification: ACTIB