Oxygen by Roberts Oxygen Company, Inc. OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Roberts Oxygen Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

ROBERTS OXYGEN
ROCKVILLE, MARYLAND 20866
TEL: (301) 948-8100

CERTIFICATE OF ANALYSIS
OXYGEN REFRIGERATED LIQUID, USP*

PRODUCED BY AIR-LIQUEFACTION PROCESS

TRAILER#: ______________

DATE:  _________________

LOT#: _________________

*USP applies only when used in a medical application or by medical customers properly registered with the FDA.

Component Test Method Limit Result

Oxygen ______ >99.5% _______

Odor ORGANOLEPTIC N/D ______

________ _________ _________ _________

Product is identified as OXYGEN, USP through process validations, dedicated piping, and product specific connections.

Notes:  _____________________________________

RELEASED BY: ____________________________

SIGNATURE

RELEASED BY: ____________________________

PRINTED NAME

Printed & Published by J.J. KELLER & ASSPCIATES, INC., Neenah, WI * USP

(800) 327-6868 *jjkeller.com * Printer in the Unitied States

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 46123-045
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	990 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46123-045-01	1 L in 1 TANK; Type 0: Not a Combination Product	01/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205849	01/01/2014

Labeler - Roberts Oxygen Company, Inc. (042646877)

Establishment
Name	Address	ID/FEI	Business Operations
Roberts Oxygen Company, Inc.		791818008	manufacture(46123-045)