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
NDC Product Code12213-801
Application NumberNDA205849
Marketing CategoryC73594
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 16, 2023
Generic NameHelium/Oxygen Mix
INGREDIENTS (2)
HELIUMInactive
Quantity: 800 mL in 1 L
Code: 206GF3GB41
Classification: IACT
OXYGENActive
Quantity: 200 mL in 1 L
Code: S88TT14065
Classification: ACTIB