Label: OXYGEN gas
- NDC Code(s): 82666-001-01
- Packager: ABSOLUTE AIR LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 17, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
PRINCIPAL DISPLAY PANEL
ABSOLUTE AIR Shipped From:
Absolute Air LLC
1305 40th Street NW
Faribault, MN 55021
763-551-5393
Certificate of Analysis
Customer Messer
Product Oxygen, USP
Time In 06/25/2022 09:02:20
Time Out 06/25/2022 09:04:27
Trailer T20
Load 1
Lot 55021-O-22-176-1-T20
Gross Weight, lbs 78500
Tare Weight, lbs 34500
Net Weight, lbs 44000
Pre-Fill Result Specification Method
Pass Pass
Post-Fill Result Specification Method
Purity, % 99.5 >= 99.0 Assay by Teledyne 3010MA Paramagnetic
H2O, ppm/V 5 N/A H2O by Teledyne 8800A Electrochemical
Odor None None Organoleptic
This product was manufactured by air liquefaction. Therefore, carbon monoxide and carbon dioxide testing is exempt under the USP compendium
Analyst: I declare that this analysis was completed within all Absolute Air policies and procedures and that the product meets Absolute Air specifications.
Signed Date/Time
Release By: I declare that this certificate is accurate, completed, and compliant with the applicable policies and procedures and that the product meets Absolute Air specifications.
Signed Date/Time
Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or an MSDS.
Signed Date/Time
-
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82666-001 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:82666-001-01 17033 L in 1 TANK; Type 0: Not a Combination Product 06/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA217500 06/30/2022 Labeler - ABSOLUTE AIR LLC (118626491) Establishment Name Address ID/FEI Business Operations ABSOLUTE AIR, LLC 118626491 manufacture(82666-001)