Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 80268-001-01 - Packager: Praxair Mexico, S. de R.L. de C.V
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 9, 2021
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- Official Label (Printer Friendly)
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Oxygen
PRAXAIR Track No:
Haciendo nuestro planeta mds productive
Certificate of Analysis (COA)
PRAXAIR MEXICO S. de R.L. de C.V.
700 Via Matamoros drive, Garza Cantu
San Nicolas de los Garza, Nuevo Leon,
64550 Mexico
Oxygen USP NDA: 210844 Customer Name:
FDA Establishment Identifier: 3004658099 Praxair Number:
DUNS Number: 812821245
LIQUID OXYGEN USP
Batch Number:
Order: Lot Number: Shipping Container:
Component Specification Analytical ResultAnalytical Method1Analyzer Used
Assay NLT 99.5% by volume ________%v/v Paramagnetic Servomex 4100
Identification Positive _________ Paramagnetic Servomex 4100
Tester’s Signature: __________________________
Reviewer’s Signature: _________________________
Quality Assurance Reviewer
Notes:1. Liquid oxygen produced by the air liquefaction process.
2. Product is identified as Oxygen by way of oxygen specific paramagnetic analyzers
3. Product is identified as oxygen through process validation, dedicated piping and product specific CGA fittings.
Date/Time: _______________________ OO/R-02-080/3-10
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80268-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80268-001-01 12310000 L in 1 CONTAINER; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA210844 08/01/2020 Labeler - Praxair Mexico, S. de R.L. de C.V (812505014) Establishment Name Address ID/FEI Business Operations Praxair Mexico, S. de R.L. de C.V 812505014 manufacture(80268-001)