Helium/Oxygen Mix
Helium/oxygen mix
Approved
Approval ID
60dd4f4b-7132-385e-e053-2a91aa0ad5d6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
NEXAIR, LLC
DUNS: 927024422
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Helium/Oxygen Mix
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12213-801
Application NumberNDA205849
Product Classification
M
Marketing Category
C73594
G
Generic Name
Helium/Oxygen Mix
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 16, 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