MedPath

Oxygen

Oxygen Label

Approved
Approval ID

78220cf7-50ca-4c79-9067-9d399f191853

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 10, 2023

Manufacturers
FDA

ROBINSON`S INDUSTRIAL GAS & EQUIPMENT CORP.

DUNS: 798062246

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 Code66487-001
Application NumberNDA205840
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxygen
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 10, 2023
FDA Product Classification

INGREDIENTS (1)

OXYGENActive
Quantity: 997 mL in 1 L
Code: S88TT14065
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/15/2018

OXYGEN, COMPRESSED USP UN1072 PRODUCED BY AIR LIQUIFACTION OXYGEN 2
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act.
DANGER: MAY CAUSE OR INTENCIFY FIRE; OXYDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire; Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use.
CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL
ROBINSON’S INDUSTRIAL GAS & EQUIPMENT CORP. 920 LINCOLN AVENUE, SUITE 14 . HOLBROOK, NY 11741 (631) 289-1982 oxygen one

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Oxygen - FDA Drug Approval Details