Helium
helium
Approved
Approval ID
2e9012ae-8ff1-4858-a1e9-e2c3959b2f57
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2023
Manufacturers
FDA
Aero All Gas Company
DUNS: 004532065
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 Code10014-004
Application NumberNDA206826
Product Classification
M
Marketing Category
C73594
G
Generic Name
Helium
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 17, 2023
FDA Product Classification
INGREDIENTS (1)
HELIUMActive
Quantity: 990 mL in 1 L
Code: 206GF3GB41
Classification: ACTIB