Helium Oxygen Nitrogen mixture
Helium Oxygen Nitrogen Mixture
Approved
Approval ID
619c58a9-7eae-450a-aa89-0027a388ce06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2023
Manufacturers
FDA
Praxair Distribution, Inc.
DUNS: 042845636
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Helium Oxygen Nitrogen mixture
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59579-010
Application NumberNDA205851
Product Classification
M
Marketing Category
C73605
G
Generic Name
Helium Oxygen Nitrogen mixture
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (3)
HELIUMActive
Quantity: 200 mL in 1 L
Code: 206GF3GB41
Classification: ACTIB
OXYGENActive
Quantity: 500 mL in 1 L
Code: S88TT14065
Classification: ACTIB
NITROGENActive
Quantity: 300 mL in 1 L
Code: N762921K75
Classification: ACTIB