Helium
Helium Label
Approved
Approval ID
cb33fc07-e122-4f66-aa43-b659ee150150
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12213-710
Application NumberNDA205851
Product Classification
M
Marketing Category
C73594
G
Generic Name
Helium
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (1)
HELIUMActive
Quantity: 999 mL in 1 L
Code: 206GF3GB41
Classification: ACTIB