Helium
Helium - Human
Approved
Approval ID
bf6e56a4-0193-4436-ae0d-cb0f0f65c2fc
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59579-005
Application NumberNDA205912
Product Classification
M
Marketing Category
C73594
G
Generic Name
Helium
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (1)
HELIUMActive
Quantity: 990 mL in 1 L
Code: 206GF3GB41
Classification: ACTIB