Heliox
Heliox 20/80
Approved
Approval ID
8529d8a5-8675-b1a4-e053-2a91aa0a914c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2023
Manufacturers
FDA
Metro Welding Supply Corporation
DUNS: 005328869
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Heliox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62273-007
Application NumberNDA205849
Product Classification
M
Marketing Category
C73594
G
Generic Name
Heliox
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