OXYGEN REFRIGERATED LIQUID, USP

OXYGEN REFRIGERATED LIQUID, USP

Drug Labeling and Warnings

Drug Details

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OXYGEN- oxygen gas 
Roberts Oxygen Company, Inc.

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OXYGEN REFRIGERATED LIQUID, USP

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

image label

OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 46123-045
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 46123-045-011 L in 1 TANK; Type 0: Not a Combination Product01/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20584901/01/2014
Labeler - Roberts Oxygen Company, Inc. (042646877)

Revised: 12/2016
 
Roberts Oxygen Company, Inc.


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