Label: OXYGEN- 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 October 5, 2023
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- WARNINGS SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Messer
Gases for Life
Certicate of Analysis - Oxygen USP
Product: Oxygen USP
Date
Facility Name
Facility Address
Lot#
Batch #
Final Analysis Results
Analyzer #
Test/Units
USP Specs
Analysis Results
N/A
Odor
None
% O2
> 99.0%
(Messer Spec >99.50%)%
ppm H2O
N/A
ppm
ppm THC
N/A
ppm
N/A
% CO
≤ .001
***
N/A
% CO2
≤ .03
***
NT= not tested
*** = This product was manufactured by Air Liquefaction and testing is exempt under the USP compendium.
The methodology used to perform the USP test:
Paramagnetic Analyzer Manufacturer / Model# : _______________________________________________This analyzer has been validated by Messer as acceptable alternatives to the official USP for Oxygen Assay. Validation study documentation is maintained by Messer at the corporate offices.
Analyst
Date
Quality Reviewer
Date
Should the material not be delivered to a USP customer, the material is “Not Approved for Human Drug Use.”
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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 943812438 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 101889988 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 081695020 manufacture(52438-011) , api manufacture(52438-011) Establishment Name Address ID/FEI Business Operations Messer LLC 872699181 manufacture(52438-011) , api manufacture(52438-011) 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 092191712 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 791242337 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 945417111 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 147344667 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 940070527 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 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 799311001 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 809794592 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 093220150 manufacture(52438-011) , api manufacture(52438-011)