Label: NITROGEN gas
-
Contains inactivated NDC Code(s)
NDC Code(s): 46123-044-01 - Packager: Roberts Oxygen Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated November 19, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
PRINCIPAL DISPLAY PANEL
ROBERTS OXYGEN
ROCKVILLE, MARYLAND 20866
TEL: (301) 948-8100CERTIFICATE OF ANALYSIS
NITROGEN REFRIGERATED LIQUID, NF*PRODUCED BY AIR-LIQUEFACTION PROCESS
TRAILER#: ______________
DATE: _________________
LOT#: _________________
*NF applies only when used in a medical application or by medical customers properly registered with the FDA.
Component Test Method Limit Result
NITROGEN DIFF >99.999% _______
OXYGEN ________ <3.0 PPM _______
Odor ORGANOLEPTIC N/D ______
________ _________ _________ _________
Product is identified as NITROGEN, NF 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
NITROGEN
nitrogen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46123-044 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46123-044-01 1 L in 1 TANK; Type 0: Not a Combination Product 07/01/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205850 07/01/2002 Labeler - Roberts Oxygen Company, Inc. (042646877) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 791818008 manufacture(46123-044)