Carbon Dioxide-Air Mixture
Carbon Dioxide - Air -117
Approved
Approval ID
be034e3c-526f-41cb-bfa0-88883232ea9b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
Roberts Oxygen Company, Inc.
DUNS: 042646877
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carbon Dioxide-Air Mixture
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46123-117
Application NumberNDA205849
Product Classification
M
Marketing Category
C73594
G
Generic Name
Carbon Dioxide-Air Mixture
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (3)
NITROGENInactive
Code: N762921K75
Classification: IACT
CARBON DIOXIDEActive
Quantity: 80 mL in 1 L
Code: 142M471B3J
Classification: ACTIB
OXYGENActive
Quantity: 210 mL in 1 L
Code: S88TT14065
Classification: ACTIB