Label: OXYGEN gas
- NDC Code(s): 52003-011-20
- Packager: Messer Canada Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 14, 2025
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PRINCIPAL DISPLAY PANEL
Plant
123 Messer St, Anytown, CanadaCertificate of Analysis - Stall 1
Product: Oxygen USP
Date: 10/27/2025
Lot#: 5138-1-0590-102725-04
Tare Weight: 40380 lbs.
Gross Weight: 79000 lbs.
Net Weight: 38620 lbs.
Net Volume: 466.53 kscfBatch #: AIT-80-4-102725-01
Logon Time: 2025-10-27 13:07:43
Analysis Finish: 2025-10-27 14:03:19
Logoff Time: 2025-10-27 14:13:53Final Analysis Results
Analyzer #
Test/Units
LOX1 Specs
Analysis Results
Limit of Detection
Organoleptic
Odor
None
None
AIT-80-4
% O₂
≥ 99.50
99.82
*****
LAB
PPM THC
N/A
NT
0.10
LAB
PPM H₂O
N/A
NT
0.01
N/A
% CO₂
≤ 0.030
***
N/A
% CO
≤ 0.001
***
NT = Not Tested
*** = This product was manufactured by Air Liquefaction and testing is exempt under the USP compendium.
% O₂ Method Used: Paramagnetic Analyzer Manufacturer/Model#: Servomex 1100
This analyzer has been validated by Messer as an acceptable alternative to the official USP for Oxygen Assay. Validation study documentation is maintained by Messer at the corporate office. LOX NDA: 205817, LOX NADA: 141373
This document contains an electronic signature.
Analyst
Date
Sample Results Obtained from Messer Validated Analyzers
10/27/2025
Quality Reviewer
Date
John Doe
10/27/2025
Should the material not be delivered to an USP customer, the material is "Not Approved for Human Drug Use"
LOX1
-
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52003-011 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 995 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52003-011-20 18144 L in 1 TANK; Type 0: Not a Combination Product 01/01/1960 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205817 01/01/1960 Labeler - Messer Canada Inc. (201613189) Registrant - Messer Canada Inc. (201613189) Establishment Name Address ID/FEI Business Operations Messer Canada Inc. 244231937 manufacture(52003-011) , api manufacture(52003-011)