Helium
HELIUM, COMPRESSED
Approved
Approval ID
483cedea-cb55-dcec-cbd2-a36a73a289cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2021
Manufacturers
FDA
Linde Gas & Equipment Inc.
DUNS: 805568339
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 Code25373-010
Application NumberNDA206826
Product Classification
M
Marketing Category
C73594
G
Generic Name
Helium
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 4, 2017
FDA Product Classification
INGREDIENTS (1)
HeliumActive
Quantity: 99 L in 100 L
Code: 206GF3GB41
Classification: ACTIB