Oxygen Helium Mixture
O2 20 HE 80 MIX
Approved
Approval ID
60ced542-19d3-57d5-e053-2a91aa0a49be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2017
Manufacturers
FDA
Aero All Gas Company
DUNS: 004532065
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxygen Helium Mixture
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10014-009
Application NumberNDA205840
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxygen Helium Mixture
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 18, 2017
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