Helium
Helium
Approved
Approval ID
b8cea45c-16b2-3daa-e053-2a95a90aa942
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2023
Manufacturers
FDA
Medical-technical Gases, Inc.
DUNS: 019481373
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Helium
PRODUCT DETAILS
NDC Product Code10736-020
Application NumberNDA205864
Marketing CategoryC73594
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 18, 2023
Generic NameHelium
INGREDIENTS (1)
HELIUMActive
Quantity: 990 mL in 1 L
Code: 206GF3GB41
Classification: ACTIB