Oxygen
oxygen
Approved
Approval ID
9aef32b3-6174-8d3e-e053-2995a90a8bf8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2023
Manufacturers
FDA
Indian River Oxygen, Inc.
DUNS: 122627206
Products 1
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 Code60980-002
Application NumberNDA205865
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxygen
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 18, 2023
FDA Product Classification
INGREDIENTS (1)
OXYGENActive
Quantity: 998 mL in 1 L
Code: S88TT14065
Classification: ACTIB