Label: OXYGEN gas
- NDC Code(s): 11853-013-60, 11853-013-61
- Packager: Air Liquide Large Industries U.S. LP
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 3, 2023
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Oxygen USP COA
AIR LIQUIDE OXYGEN U.S.P. Form Number: 2A-ALL-QUA-0005-F
Revision: 0
Effective Date: 03/29/06
Page: 1/1
CERTIFICATE OF ANALYSIS
Air Liquide large Industries U.S. L.P. – Houston, TX 77056
PRODUCED BY AIR LIQUEFACTION
1.Location Street Address1 2. Carrier ________________
Street Address 2
City, State Zip
3. Lot Number ______________________ 4. Trailer No _____________
PRE-FILL REPORT FILL REPORT
5.Residual Assay 6. Odor 7. Trailer loaded with appropriate product per appropriate
(>99.5% O2) Detected loading procedure by:
_______ % Yes No Signature _________________________
________ ________ Date _____________________________
Initial Initial
ANALYSIS REPORT
Test required Method of Analysis Specifications Results
OXYGEN ASSAY PARAMAGNETIC ___ 99.5% O2 Minimum 9. ____%
8.Analyzer Tag Number
ODOR Organoleptic (Nasal) None 10. ______
USP applies only when used in a medical application or by medical customers properly registered with the FDA. Note: Oxygen that is produced by the air liquefaction process is exempt from the requirement of the impurity test for Carbon Dioxide and Carbon Monoxide.
11. Analyzed By ________________________ Date ____________
12. Witnessed By ________________________ Date ____________
(only required for HRC customers)
13. Does this lot require additional testing? ___ NO ___ YES – attach page 2
14. SQCU Review/Release _______________________ Date ____________
MANDATORY FORM
User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11853-013 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11853-013-60 25000 L in 1 TANK; Type 0: Not a Combination Product 01/01/1960 2 NDC:11853-013-61 50000 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 NDA205737 01/01/1960 Labeler - Air Liquide Large Industries U.S. LP (180015062) Registrant - Air Liquide Large Industries U.S. LP (180015062) Establishment Name Address ID/FEI Business Operations Air Liquide Large Industries U.S. LP 791294122 manufacture(11853-013) Establishment Name Address ID/FEI Business Operations Air Liquide Large Industries U.S. LP 832290014 manufacture(11853-013) Establishment Name Address ID/FEI Business Operations Air Liquide Large Industries U.S. LP 831993303 manufacture(11853-013) Establishment Name Address ID/FEI Business Operations Air Liquide Large Industries U.S. LP 047089305 manufacture(11853-013) Establishment Name Address ID/FEI Business Operations Air Liquide Large Industries U.S. LP 111765132 manufacture(11853-013) Establishment Name Address ID/FEI Business Operations Air Liquide Large Industries U.S. LP 117158467 manufacture(11853-013)