Label: OXYGEN gas
- NDC Code(s): 52438-011-20
- Packager: Messer LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 12, 2025
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PRINCIPAL DISPLAY PANEL
Plant
123 Messer St, Anytown, USACertificate 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: 205767, LOX NADA: 141365
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
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52438-011 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:52438-011-20 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 NDA205767 01/01/1960 Labeler - Messer LLC (001368141) Registrant - Messer LLC (001368141) Establishment Name Address ID/FEI Business Operations Messer LLC 002123321 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 003000197 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 004212362 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 019983468 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 026946218 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 041268947 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 042263707 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 079481211 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 081695020 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 092191712 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 093220150 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 101889988 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 102835006 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 108034669 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 147344667 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 192602431 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 791242337 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 799311001 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 809794592 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 839692303 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 872699181 api manufacture(52438-011) , manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 940070527 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 943812438 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 945417111 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 969312248 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer North America, Inc. 057695412 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 119239875 manufacture(52438-011) , api manufacture(52438-011)