Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 64540-001-01, 64540-001-02, 64540-001-03, 64540-001-04, view more64540-001-05 - Packager: Austin Respiratory Equipment,inc.
- This is a repackaged label.
- Source NDC Code(s): 11390-001
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 13, 2017
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64540-001(NDC:11390-001) 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:64540-001-01 170 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package 07/11/2011 2 NDC:64540-001-02 255 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package 07/11/2011 3 NDC:64540-001-03 450 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package 07/11/2011 4 NDC:64540-001-04 680 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package 07/11/2011 5 NDC:64540-001-05 1738 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package 07/11/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 07/11/2011 Labeler - Austin Respiratory Equipment,inc. (849265483) Registrant - Austin Respiratory Equipment,inc. (849265483) Establishment Name Address ID/FEI Business Operations Austin Respiratory Equipment,inc. 849265483 relabel(64540-001)
