OXYGEN
Oxygen
Approved
Approval ID
a116dc52-9522-4cc3-b745-0b0cc3e0d7dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
Indiana Oxygen Company Inc
DUNS: 006036776
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OXYGEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code48546-0002
Application NumberNDA205767
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYGEN
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateFebruary 11, 2022
FDA Product Classification
INGREDIENTS (1)
OXYGENActive
Quantity: 99.5 L in 100 L
Code: S88TT14065
Classification: ACTIB
OXYGEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code48546-0006
Application NumberNDA205767
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYGEN
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateFebruary 11, 2022
FDA Product Classification
INGREDIENTS (1)
OXYGENActive
Quantity: 99 L in 100 L
Code: S88TT14065
Classification: ACTIB
OXYGEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code48546-0004
Application NumberNDA205767
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYGEN
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateFebruary 11, 2022
FDA Product Classification
INGREDIENTS (1)
OXYGENActive
Quantity: 99.6 L in 100 L
Code: S88TT14065
Classification: ACTIB
OXYGEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code48546-0001
Application NumberNDA205767
Product Classification
M
Marketing Category
C73594
G
Generic Name
OXYGEN
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateFebruary 11, 2022
FDA Product Classification
INGREDIENTS (1)
OXYGENActive
Quantity: 99 L in 100 L
Code: S88TT14065
Classification: ACTIB