Helium
Helium -200
Approved
Approval ID
eb561a7a-9c50-3660-e053-2a95a90a97e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2023
Manufacturers
FDA
General Air Service & Supply Co
DUNS: 051227338
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 Code21220-200
Application NumberNDA216307
Product Classification
M
Marketing Category
C73594
G
Generic Name
Helium
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 18, 2023
FDA Product Classification
INGREDIENTS (1)
HELIUMActive
Quantity: 990 mL in 1 L
Code: 206GF3GB41
Classification: ACTIB