Helium
Helium
Approved
Approval ID
7046ef16-a4f4-15b7-e053-2a91aa0a4f1a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2023
Manufacturers
FDA
A-OX WELDING SUPPLY CO., INC.
DUNS: 024372385
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 Code10297-006
Application NumberNDA211781
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